Clinical trial NCT03103061
Conditions: Cardiovascular Diseases Coronary Artery Disease
Keywords: Computed Tomography
Sponsor: Medical University of South Carolina
Start date: 2016-02-09; Completion date: 2018-06-14
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the feasibility, tolerability, safety, and image quality of low-radiation, dynamic perfusion CT of the heart in patients with suspected ischemic chest pain and a moderate or severe stenosis seen on coronary CTA. Secondary aims include the assessment of the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.

Detailed description:

Arms: arm 1: Low-radiation, dynamic perfusion CT of the heart in patients with suspected ischemic chest pain and a moderate or severe stenosis seen on coronary CTA. Lexiscan(TM) will be used as the pharmacological stress agent (coronary vasodilator).
Interventions: intervention 1: Lexiscan
Intervention descriptions: intervention 1: Coronary vasodilator

Protocol documents:
Prot_SAP_000.pdf: 
 
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Clinical Study Protocol 
 
Use of Lexiscan™ for Myocardial Stress Perfusion Computed 
Tomography with a 3rd Generation Dual Source CT System 
 
 
Principal Investigator:   
U. Joseph Schoepf, MD 
Origination Date:  
 
07/06/2015 
 
Medical University of South Carolina 
Department of Radiology and Radiological Science 
25 Courtenay Drive 
Charleston, SC29425 
 
 
 
 
 
 
CONFIDENTIALITY STATEMENT 
 
This document is the confidential property of Medical University of South Carolina, Radiology 
Department.  No Part of it may be transmitted, reproduced, published or used by other persons 
without the permission of the Principal Investigator. 
 
 


 
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Version Date: 05.11.2017 
 
 
Use of Lexiscan™ for Myocardial Stress Perfusion Computed 
Tomography with a 3rd Generation Dual Source CT System 
 
Table of Contents 
A.  SPECIFIC AIMS 
3 
B.  BACKGROUND AND SIGNIFICANCE 
3 
C.  PRELIMINARY STUDIES 
3 
D.  RESEARCH DESIGN AND METHODS (including data analysis) 
4 
D.1  
Research Design 
4 
D.2 
Statistical Methods / Sample Size Justification 
10 
E.  PROTECTION OF HUMAN SUBJECTS 
11 
E.1 
RISK TO THE SUBJECTS 
11 
E.1.a  Human Subject Involvement and Characteristics 
11 
E.1.b Sources of Materials 
14 
E.1.c Potential Risks 
14 
E.2   ADEQUACY OF PROTECTION AGAINST RISKS 
17 
E.2.a   Recruitment and Informed Consent 
17 
E.2.b  Protection against Risk 
18 
E.3  
POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND OTHERS 
19 
E. 4  IMPORTANCE OF THE KNOWLEDGE TO BE GAINED 
19 
E.5  
SUBJECT SAFETY AND MINIMIZING RISKS (Data and Safety Monitoring Plan) 
19 
F.  REFERENCES 
22 
G.  FACILITIES AVAILABLE 
22 
H.  APPENDIX 
22 
 
Medical University of South Carolina 


 
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A.  SPECIFIC AIMS 
Primary Study Aim: The purpose of this study is to evaluate the feasibility, tolerability, safety, and 
image quality of low-radiation, dynamic perfusion CT of the heart in patients with suspected 
ischemic chest pain and a moderate or severe stenosis seen on coronary CTA.   
The main hypothesis is that CTA with stress and rest perfusion imaging using Lexiscan™ as the 
coronary vasodilator will be safe, well tolerated, have lower radiation dose, acceptable image quality 
and be much faster than conventional nuclear perfusion imaging. 
 
Secondary Study Aim: The secondary purpose of this study will be to assess the diagnostic accuracy 
of CT perfusion imaging compared to either SPECT, MRI stress perfusion, or invasive angiography.   
Since we expect to be underpowered to prove that CT perfusion is noninferior to SPECT and/or MRI 
stress perfusion, we will not do any preplanned statistical comparison of the accuracy for diagnosing 
significant CAD between CT perfusion and SPECT/MRI stress perfusion. Because all patients will not 
have invasive angiography, we cannot do analysis for sensitivity or specificity for detection of CAD 
against this gold standard. Furthermore, we believe that SPECT is an imperfect gold standard against 
which to judge CT (i.e., SPECT has well known problems with specificity and to a lesser extent 
sensitivity). However, we will present the comparison of findings with each modality on a per-patient 
and per-segment basis so that they can be used to help plan subsequent larger, head to head studies 
that are powered to compare the accuracy of each modality. 
 
B.  BACKGROUND AND SIGNIFICANCE 
Chest pain is one of the most common reasons for emergency department (ED) visits. Rapid and 
accurate identification of those with acute coronary syndromes allows immediate institution of 
appropriate treatment and safe discharge of those with non-cardiac causes of chest pain. Current 
approaches are time consuming, costly, and fraught with errors. A testimony to the problems of our 
current approach to evaluation of chest pain is the sobering report that more than 50% of patients 
undergoing invasive coronary angiography in this country are found to have nonobstructive coronary 
artery disease (CAD).1 This most likely results from both false positive and false negative results from 
current noninvasive tests.2 Several recent randomized trials have shown advantages of coronary CT 
angiography as the initial diagnostic test for patients presenting with chest pain in the ED setting.3-5  
However, two major concerns about the routine use of coronary CTA in ED patients with suspected 
cardiac ischemia are: 1) high radiation exposure from the CT scan, and 2) the problem of defining the 
significance of moderate stenosis identified on CT coronary imaging.  The goal of this study is to 
address both of these issues by: 1) using a novel, 3rd generation CT scanner that is capable of 
coronary imaging and perfusion assessment at very low radiation doses, and 2) combining coronary 
(anatomic) imaging with rest and “stress” perfusion (functional) imaging using Lexiscan™ as the 
coronary vasodilating agent.  Addition of perfusion imaging to the anatomic information provided by 
CTA has the potential to reduce the number of false positive interpretations and thereby improve 
specificity and positive predictive value.  
 
C.  PRELIMINARY STUDIES 
Using 1st and 2nd generation dual source CT, we were the first group worldwide able to demonstrate 
the feasibility and usefulness of the assessment of myocardial perfusion with CT. Our initial findings 
have been accepted and published in various journals (e.g. Ruzsics Circulation 2008, Eur Radiol 2008, 


 
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and Am J Cardiol 2009; Bastarrika, Invest Radiol 2010, J Cardiovasc Comput Tomogr 2010; Meinel 
2014, AJR Am J Roentgenol).  
 
The SOMATOM™ Force is a new CT system, and currently no published data involving myocardial 
perfusion CT are available. However, the vendor has issued estimates on the enhanced performance 
of this new system that indicate a >20% reduction in radiation dose in all routine scans. Furthermore, 
cardiac imaging such as CTA and perfusion studies could result in up to a 50% reduction in total 
radiation dose. Given the technological advances detailed above we have confidence that these data 
will be realized in practice. 
 
In addition, our research group has a proven track record of conducting CT studies on reductions in 
radiation dose and contrast material employing the previous generation of CT systems, such as the 
SOMATOM™ Definition and the SOMATOM™ Definition Flash. We have also conducted pioneering 
research in the novel applications of dual source CT with a focus on cardiovascular indications. In 
brief, these studies include the following: 
 
studies evaluating novel dose-lowering acquisition techniques such as ECG-dependent tube 
current modulation8, anatomic tube current modulation9, prospective ECG-triggering10 and 
high-pitch acquisition11 
 
studies on optimizing contrast injection protocols12-15 
 
studies in specific patient populations such as obese patients11 and pediatric patients9,12 
 
studies using novel reconstruction techniques for dose reduction18,19 
 
studies on specific difficult-to-image clinical scenarios, such as the evaluation of coronary 
stents20-21 and heavily calcified coronary vessels22. 
 
D.  RESEARCH DESIGN AND METHODS (INCLUDING DATA ANALYSIS)  
D.1  RESEARCH DESIGN 
 
This study will include 100 adults who present to the MUSC ED, hospital, or outpatient clinic with a 
clinical history and symptoms suspicious for cardiac ischemia and who have undergone or will likely 
undergo nuclear stress testing (SPECT) or who have undergone MRI stress perfusion imaging.  
 
Patients who have been referred for a coronary CTA performed as part of a standard clinical 
evaluation determined by the treating physician(s) will be eligible for the study and recruited from 
the MUSC CT schedule. Before the patient comes in for their clinical coronary CTA, their cardiologist 
or primary physician will be contacted to ensure patient interest in the study and willingness to be 
approached. Willing patients will be approached and will undergo the informed consent process. 
Consented subjects will first undergo their clinically indicated coronary CTA; if there is no moderate 
or significant stenosis on the CTA following an initial interpretation (i.e., normal or near-normal 
coronary arteries), the patient will not undergo the stress CT perfusions portion of the study and will 
have their usual care without further testing for cardiac ischemia. However, these patients will be 
included in the data analysis, belonging to the negative CT population (see Patient Flow Chart below). 
Patients with moderate, indeterminate, or significant stenosis of any major or large branch epicardial 
vessel on the CTA will then undergo the stress CT perfusion study. According to current guidelines, it 


 
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is to be expected that this group of patients will also be clinically referred for further ischemia 
workup with either SPECT or coronary catheter angiography. 
 
Patients who have undergone SPECT without referral for cardiac CTA will also be eligible for this 
study. For these patients, the coronary CT at rest will be performed as a research procedure followed 
by the stress portion of the CT perfusion study. No interpretation will be performed before the stress 
portion of the exam so all of these patients will receive the stress portion of the exam. These patients 
must have the clinically indicated SPECT as well as the research cardiac CTA with CT perfusion study 
completed within 60 days. 
 
Patients who have undergone SPECT with a prior cardiac CTA will also be eligible for this study. These 
patients will only undergo the stress portion of CT perfusion study. These patients must have the 
clinically indicated cardiac CTA and SPECT as well as the research CT perfusion study completed 
within 60 days. 
 
Patients who have undergone MRI perfusion imaging without referral for cardiac CTA will also be 
eligible for this study. For these patients, the coronary CT at rest will be performed as a research 
procedure followed by the stress portion of the CT perfusion study. No interpretation will be 
performed before the stress portion of the exam so all of these patients will receive the stress 
portion of the exam. These patients must have the clinically indicated MRI stress perfusion imaging 
as well as the research cardiac CTA with CT perfusion study completed within 60 days. 
 
Patients who have undergone MRI stress perfusion imaging with a prior cardiac CTA will also be 
eligible for this study. These patients will only undergo the stress portion of CT perfusion study. 
These patients must have the clinically indicated cardiac CTA and SPECT as well as the research CT 
perfusion study completed within 60 days. 
 
The CT perfusion scans will be analyzed and read by two highly trained CT readers (cardiologist and 
radiologist).  In addition to assessing the safety and tolerability of the Lexiscan™ perfusion study, the 
CT perfusion findings will be compared diagnostically to SPECT and/or invasive catheter angiography 
if this is performed clinically after the research procedure. 
 


 
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Patient Flow Chart 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patients with heart rates > 65 bpm may receive beta-blockers in order to reduce their heart rate to 
values < 60 bpm. Patients with contraindications to the use of beta-blockers (chronic obstructive 
pulmonary disease, asthma sensitive to beta agonists, second- or third-degree heart block, 
hypotension as defined by systolic blood pressure <100 mmHg) are in principle eligible for 
participation in the study – however, no beta-blockers will be used in such individuals. Patients will 
receive nitroglycerin based on investigator judgment to better visualize the coronary arteries. Female 
subjects of childbearing potential will be given a urine pregnancy test prior to study enrollment. 
Pregnant persons will be excluded. Patients will receive a point-of-care serum creatinine test on the 
day of their research procedure before any contrast administration and patients with a serum 
creatinine greater than or equal to 1.5 mg/dL will be excluded from the study.  
 
Patient population (n=100) 
Symptoms suspicious for cardiac ischemia 
Clinical referral for coronary CTA 
Coronary CTA 
Coronary CTA with initial 
read 
Negative CT 
 Mild or minimal 
stenosis 
CT Perfusion Imaging 
n=30 
Negative Population  
(no further study procedures) 
n=70 
SPECT or MRI stress perfusion 
imaging with prior CTA  
 
Positive CT 
 Moderate or 
significant stenosis 
 Prior SPECT or likely 
to undergo further 
testing (SPECT, ICA) 
SPECT or MRI stress perfusion 
without clinical referral for 
coronary CTA 


 
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CT Coronary Angiography Protocol: 
Studies will be performed using a 3rd generation, dual source CT scanner capable of coronary imaging 
at < 1mSv (Siemens, SOMATOM™ Force). The coronary CTA will be performed based on standard 
clinical indications that conform to published appropriate use criteria. The scan will be done using 
our usual clinical protocol with administration of 30 – 60 cc of an intravenous contrast agent 
(Ultravist 370). Acquisition mode (axial, prospective, retrospective or flash) is chosen based on heart 
rate, rhythm and body size.  We will accept patients who have the SPECT study done within 30 days 
of the scheduled CTA and/or research scan(s).   
 
Pharmaceutical Stress Protocol: 
Pharmacological stress testing will be performed with a single injection of 0.4. mg of regadenoson 
(Lexiscan™) under physician and nursing supervision per MUSC clinical protocol. The cardiologist 
responsible for clinical stress administration will review a pre-Lexiscan™ EKG and patient medical 
history to ensure Lexiscan™ can be administered safely. A post-Lexiscan™ EKG will be obtained and 
read and the cardiologist will determine if and when the patient can be discharged safely. 
 
Analysis of CT Coronary Angiography Images: 
CT coronary angiograms will be evaluated by consensus of two experienced investigators.  Images 
will be analyzed using both axial source images and by analyzing dedicated 2D and 3D visualization 
techniques such as Maximum Intensity Projection (MIP), curved Multiplanar Reconstruction (MPR) 
and 3D Volume Rendering (VRT). 
 
CT myocardial perfusion protocols: 
Patients will undergo dynamic, first pass, stress perfusion imaging during maximal hyperemia 
induced with Lexiscan™.  Imaging will commence approximately 90 seconds after a bolus of 
Lexiscan™ (0. 4 mg per each 5 mL injection).  The Lexiscan™ is followed immediately by a bolus of 10 
cc saline.  In order to achieve the correct timing of the dynamic image acquisition, contrast 
administration will begin approximately 80 seconds after the Lexiscan™ bolus to allow the contrast to 
reach the heart at the moment of maximal hyperemia.  Data will be acquired for 30 seconds with 
both X-ray tubes set at 80 – 100 kV, a gantry rotation time of 0.28 seconds, and a tube current of 300 
mAs per rotation.  Temporal resolution is approximately 75 ms. Patients will be instructed to hold 
their breath for the first 15 seconds of the scan, as this is the most important portion of the data 
acquisition for quantifying myocardial blood flow.  They will then be instructed to breath shallowly 
for the remaining 15 seconds. Perfusion imaging is performed in an ECG-triggered shuttle mode in 
which the table shifts between two z-positions of the heart to allow coverage of nearly the entire left 
ventricle.  End systolic imaging is used to reduce motion artifacts, to image the heart at its smallest 
dimensions, and to reduce beam-hardening artifacts from contrast in the LV cavity. The relatively fast 
rotation time combined with the dual source system gives markedly improved temporal resolution, 
which helps to reduce motion artifacts associated with the rise in heart rate that frequently occurs 
after Lexiscan™ administration. With a detector width of 38 mm and 10% overlap between the two 
imaging positions, the coverage of the acquisition is 73 mm. In some patients, small portions of the 
base or apex could be cut off.  A total of 14 or 15 image volumes during myocardial passage of the 
contrast bolus will be acquired.  CT MPI studies will use 40 – 50 mL of contrast agent (Ultravist 370) 
administered at a flow rate of 4 – 6 mL/s.  Following the perfusion imaging, the Lexiscan™ will be 


 
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reversed with 1 mg/kg of aminophylline per standard clinical protocol if indicated by the supervising 
physician. 
 
CT Perfusion Data Reconstruction and Analysis: 
Dynamic CT MPI data are reconstructed with a section thickness of 3 mm and a 2 mm increment with 
a medium smooth convoluted kernel (B30). The data are processed with the volume perfusion CT 
body application software and workstation (Siemens). After motion correction and 4D noise 
reduction, a double arterial input function is defined by placement of ROIs in the descending aorta in 
the cranial and caudal regions of the covered volume. After a volume of interest is manually defined 
around the left ventricle, the left ventricular myocardium is automatically segmented. A dedicated 
parametric deconvolution algorithm based on a two-compartment model of intravascular and 
extravascular space is used to derive myocardial blood flow and the volume transfer constant (ktrans) 
from the time-attenuation curves for each voxel.23  
 
Quantitative Measures of Myocardial Blood Flow from CT: 
CT perfusion images will be analyzed on a dedicated console using commercially available software 
(Syngo Volume Perfusion™) as previously described.24 Evidence of ischemia will be determined 
initially by visual comparison of rest and stress CT perfusion scans. Perfusion defects will be visually 
rated as reversible (only present at stress), fixed (present at both rest and stress) and mixed (more 
pronounced at stress, partly reversible at rest). Quantitative analysis of myocardial perfusion will be 
performed and mean blood volume (MBV), mean blood flow (MBF), and mean transit time (MTT) of 
each myocardial segment will be recorded. Readers will be blinded to the results of SPECT or invasive 
angiography examinations. The values obtained will be compared to historical published values for 
each parameter (MBF, MBV, and MTT) obtained using older generation CT perfusion protocols, MRI 
perfusion, or dynamic perfusion scanning.  
 
Analysis of SPECT images: 
SPECT will be used as a comparator for the CT perfusion images. SPECT examinations will be 
interpreted for perfusion defects by two experienced readers (one nuclear medicine physician and 
one cardiologist).  Images will be analyzed on a dedicated console using commercially available 
software. Evidence of ischemia will be determined by visual comparison of rest and stress SPECT 
perfusion scans as well as quantitative analysis available through the commercial analysis program.  
Perfusion defects will be visually rated as reversible, fixed, or mixed.  Readers will be blinded to the 
results of CT perfusion data and invasive coronary angiography examinations. 
 
Analysis of MRI stress perfusion images: 
MRI stress perfusion imaging will be used as a comparator for the CT perfusion images. MRI 
examinations will be interpreted for perfusion defects by two experienced readers (one radiologist 
and one cardiologist).  Images will be analyzed on a dedicated console using commercially available 
software. Evidence of ischemia will be determined by visual comparison of rest and stress MRI 
perfusion scans as well as quantitative analysis available through the commercial analysis program.  
Perfusion defects will be visually rated as reversible, fixed, or mixed. Readers will be blinded to the 
results of CT perfusion data and invasive coronary angiography examinations. 
 


 
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Image Quality: 
Subjective assessment of image quality, coronary artery visualization, and perfusion images will be 
performed by two independent observers using a semiquantitative rating scale of 0 – 5. Image 
quality will be graded on a five-point scoring system: 1 non-diagnostic; 2 limited diagnostic value; 3 
adequate (presence of artifacts not limiting detection of luminal stenosis); 4 good; 5 excellent.   
 
All measurements and calculations will be performed by one observer who will be blinded to image 
acquisition parameters.  We will also measure the signal-to-noise ratio (SNR) and contrast-to-noise 
ratio (CNR) for the coronary CTA and the perfusion images. Circular regions of interest will be placed 
in the aortic root at the level of the left main coronary artery ostium (size 100 mm2) as well as in the 
proximal segments of the left and right coronary arteries and the left lateral ventricular wall (size 1 – 
4mm2). Signal intensity (CT number in HU) and noise (HU standard deviation) will be recorded in each 
region. All regions-of-interest will be measured three times and mean measurements will be used for 
statistical analysis. The SNR will be calculated as the mean HU divided by the mean image noise 
measured in the aorta. The CNR will be calculated by subtracting the mean HU in the left lateral 
ventricular wall from the mean HU within the lumen of the proximal coronary arteries and dividing 
this difference by the image noise measured in the aorta.26 These values (SNR and CNR), although 
standard measures of image quality in CT research, cannot be compared directly between CT and 
SPECT. However, they can be used as a quantitative gauge to compare image quality between the 3rd 
generation CT scanner with low radiation imaging and the older CT perfusion scans that required 
higher radiation exposure.  
 
Analysis of radiation dose:  
The CT dose index and dose-length product will be recorded by the scanner and collected for each 
image acquisition. Effective radiation dose will be calculated by using a standard conversion factor of 
0.0145 for adult chest CT 27. For SPECT examinations, the effective radiation dose will be estimated 
by multiplying the administered activity of 99mTc-tetrofosmin with a tracer-specific conversion factor 
of 0.008 for rest and 0.0069 for stress acquisition. The effective radiation doses of rest and stress 
SPECT acquisition with then be combined to computer the net radiation dose28. The radiation dose of 
the CT myocardial perfusion will be compared with the radiation dose obtained with the previous 
(older) scanner at our institution in order to have a direct comparison of the radiation exposure 
decrease to the patient. Patients who have MRI stress perfusion imaging as the comparative imaging 
study will be excluded from the radiation dose analysis. 
 
Safety and Tolerability Assessment: 
A checklist will be made and each of the following events will be assessed by an investigator or 
designated personnel: 
1. Hypotension (systolic BP < 90 or > 30 mm Hg decrease from baseline) 
2. Hypertension (systolic BP > 200 mmHg) 
3. Significant new heart block (type II 2nd degree or 3rd degree A-V block) 
4. Bradycardia (heart rate < 45 bpm, sinus bradycardia or junctional rhythm) 
5. Bronchospasm (requiring inhaler or other medical treatment) 
6. Allergic reaction (hives, erythema, wheezing) 


 
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7. Chest pain 
8. Nausea 
9. Headache 
10. Seizures 
Additionally, a patient satisfaction questionnaire (detailed below) will be administered to all patients 
who undergo the CT perfusion scan following the research scan as well as a 30-day event rate (MACE 
defined by ED visit, hospitalization, ACS/MI, stroke, revascularization, significant new arrhythmia and 
death) will be assessed by chart review and follow-up phone call one month (+/- 3 days) from the 
scan. 
 
Patient Satisfaction Survey: 
Following the CT perfusion scan, the patient will be given a participant satisfaction survey. The 
purpose of this survey is to assess the patients’ subjective experience with the different imaging 
modalities (CT vs. SPECT/MRI stress perfusion imaging). The seven question survey will assess: 1) the 
patient’s perception of the overall ease or difficulty of the study, 2) length of the study, 3) perceived 
discomfort, 4) level of apprehension, 5) understanding of the nature of the test, 6) understanding of 
the results and 7) willingness to undergo the test again. Each question will have a quantitative score 
of 1 – 4. Patients who have not yet undergone SPECT imaging at the time will be asked the SPECT 
specific questions at the time of the 30-day follow-up if they have undergone the SPECT testing at 
that time. If not, the patient will not be asked the SPECT questionnaire.  
 
 
D.2 
STATISTICAL METHODS / SAMPLE SIZE JUSTIFICATION 
This study is intended to primarily demonstrate feasibility, safety, and tolerability of Lexiscan™ for 
use as a coronary vasodilator during perfusion CT imaging. The study is not powered to prove the 
diagnostic accuracy of perfusion CT imaging with low radiation compared to SPECT or the current 
gold standard approach of invasive coronary angiography with invasive fractional flow reserve (FFR) 
measurement. Nonetheless, we will use the available comparative data for each technique (SPECT, 
MRI stress perfusion imaging,  and invasive angiography) to help design subsequent clinical trials that 
are adequately powered for an accuracy endpoint. We anticipate that about 15 out of the 30 
participants who undergo the CT perfusion portion of the study will have available cath 
comparisions. 
 
Continuous data are displayed as mean ± SD, if normally distributed, or median and interquartile 
range if not normally distributed. Binary data are are displayed as proportions.  Data will be reported 
as means ± SD or rates with 95 percent confidence intervals. A difference with P value of 0.05 or less 
will be considered significant. 
 
Subjective image quality scores will be compared using the Chi-squared test with the Yates continuity 
correction for categorical variables and inter-observer agreement for image quality will be calculated 
using Cohen kappa (Ƙ) statistics and interpreted as follows: ≤ 0.20 slight or poor agreement, 0.20 – 
0.40 fair agreement, 0.40 – 0.80 moderate agreement, ≥ 0.80 excellent agreement. For each group, 
comparisons of patient characteristics will be performed using the Chi-squared test for categorical 
variables and t-test or Mann-Whitney-U-test for continuous variables as appropriate. 


 
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Quantitative data (CNR, radiation dose) will be tested using a non-parametric significance test. 
 
We will present comparisons of normal or abnormal perfusion determined from SPECT/MRI stress 
perfusion imaging or CT perfusion using the standard 17-segment model. We will also present a 
comparison of ischemia by CT perfusion (based on vascular territory) compared to anatomic 
evidence of significant CAD at catheterization. Any segments cut off by the limited z-axis scan range 
on perfusion CT will be excluded. Given 30 patients, we will have a maximum of 510 regions available 
to compare CT perfusion and SPECT/MRI stress perfusion. We will first perform a binary analysis 
where each segment is classified as either normal or abnormal, since the relative severity of 
perfusion defects has not been defined for CT.  If feasible based on the number of patients with 
SPECT/MRI stress perfusion scans scans, we will compare the number of abnormal segments in each 
patient by each methodology using a kappa statistic. We will also use standard SPECT/MRI stress 
perfusion grading of perfusion (1 – 4 scale) and a similar scale for CT perfusion defect severity (also 1 
– 4) based on prior measurements of absolute myocardial perfusion (ml/100 ml/min) with each 
segment graded as 1, 2, 3 or > 4 standard deviations from the norm. We will then perform linear 
regression (Pearson’s correlation) to derive R values for CT perfusion versus SPECT/MRI stress 
perfusion imaging perfusion grade for each segment. 
  
 
E.  PROTECTION OF HUMAN SUBJECTS 
E.1 
RISK TO THE SUBJECTS 
E.1.a  Human Subject Involvement and Characteristics 
 
This study will include 100 adults who present to the MUSC ED, hospital, or outpatient clinic with a 
clinical history and symptoms suspicious for cardiac ischemia and who have undergone or will likely 
undergo nuclear stress testing (SPECT).   
 
Patients who have been referred for a coronary CTA performed as part of a standard clinical 
evaluation determined by the treating physician(s) will be eligible for the study and recruited from 
the MUSC CT schedule. Before the patient comes in for their clinical coronary CTA, their cardiologist 
or primary physician will be contacted to ensure patient interest in the study and willingness to be 
approached. Willing patients will be approached and will undergo the informed consent process. 
Consented subjects will first undergo their clinically indicated coronary CTA; if there is no moderate 
or significant stenosis on the CTA following an initial interpretation (i.e., normal or near-normal 
coronary arteries), the patient will not undergo the stress CT perfusion portion of the study and will 
have their usual care without further testing for cardiac ischemia.  However, these patients will be 
included in the data analysis, belonging to the negative CT population. Patients with moderate, 
indeterminate, or significant stenosis of any major or large branch epicardial vessel on the CTA will 
then undergo the stress CT perfusion study. According to current guidelines, it is to be expected that 
this group of patients will also be clinically referred for further ischemia workup with either SPECT or 
coronary catheter angiography. 


 
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We will also target patients who have undergone SPECT without referral for cardiac CTA; in this case, 
the coronary CT at rest will be performed as a research procedure with the stress portion following in 
all cases. The CT perfusion scans will be analyzed and read by two highly trained CT readers 
(cardiologist and radiologist).  In addition to assessing the safety and tolerability of the Lexiscan™ 
perfusion study, the CT perfusion findings will be compared diagnostically to SPECT and/or invasive 
catheter angiography if this is performed clinically after the research procedure. These patients must 
have the clinically indicated SPECT as well as the research cardiac CTA with CT perfusion study 
completed within 60 days. 
 
Patients who have undergone SPECT with a prior cardiac CTA will also be eligible for this study. These 
patients will only undergo the stress portion of CT perfusion study. These patients must have the 
clinically indicated cardiac CTA and SPECT as well as the research CT perfusion study completed 
within 60 days. 
 
Patients who have undergone MRI perfusion imaging without referral for cardiac CTA will also be 
eligible for this study. For these patients, the coronary CT at rest will be performed as a research 
procedure followed by the stress portion of the CT perfusion study. No interpretation will be 
performed before the stress portion of the exam so all of these patients will receive the stress 
portion of the exam. These patients must have the clinically indicated MRI stress perfusion imaging 
as well as the research cardiac CTA with CT perfusion study completed within 60 days. 
 
Patients who have undergone MRI stress perfusion imaging with a prior cardiac CTA will also be 
eligible for this study. These patients will only undergo the stress portion of CT perfusion study. 
These patients must have the clinically indicated cardiac CTA and SPECT as well as the research CT 
perfusion study completed within 60 days. 
 
Only patients with initially negative biomarkers and non-specific-ECG findings will be considered for 
inclusion in the study in accordance with the Lexiscan package insert.  Patients will be screened by 
approved study personnel from the MUSC SPECT and CT schedules under a HIPAA waiver.  Study 
eligibility determination and study enrollment will be assessed and performed by and investigator in 
concert with a study coordinator delegated by the PI and approved by the IRB as being authorized to 
obtain informed consent. The potential use of Lexiscan™ and beta-blockers will be discussed with the 
responsible physician of record, potential contraindications will be ruled out and permission to 
approach the patient for possible inclusion will be sought.  If the patient is agreeable, they will be 
approached by one of the licensed physician investigators or designated study coordinators listed on 
the protocol either prior to or on the day of the CT scan, with a full explanation and request for 
consent as required by the IRB.  MUSC policies regarding patient consent will be followed. 
 
The study will be performed in tight collaboration between the Department of Radiology and the 
Divisions of Cardiology and Emergency Medicine. 
 
Inclusion criteria: 
To be eligible for the study: (All answers must be “YES” for subject to be eligible.) 


 
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1. Subject must present with symptoms (e.g. chest pain) suspicious for cardiac ischemia as 
determined by treating physician.  
2. Subject must have been referred for cardiac CT angiography OR subject must have 
undergone clinically indicated SPECT OR subject must have undergone clinically indicated 
SPECT with prior cardiac CT angiography OR subject must have undergone a clinically 
indicated MRI stress perfusion imaging. 
3. Subject must be 18 – 85 years of age. 
4. Subject must provide written informed consent prior to any study-related procedures being 
performed.  
5. Subject must be willing to comply with all clinical study procedures. 
 
 
 
Exclusion Criteria: 
The presence of the following excludes subjects from the study: (All answers must be “NO” for 
subject to be eligible.) 
1. Subject is a pregnant or nursing female. Exclude the possibility of pregnancy: 
- 
By testing (serum or urine beta HCG) within 24 hours before study agent 
administration, or 
- 
By surgical sterilization, or 
- 
Post menopausal, with minimum one (1) year history without menses. 
2. Subject has severe asthma or COPD requiring frequent inhaler use. 
3. Subject has prior diagnosis of obstructive CAD that has not been revascularized. 
4. Subject with implanted rhythm devices (pacemaker, defibrillator). 
5. Subject has significant arrhythmia. 
6. Subject has high grade heart block. 
7. Subject has resting heart rate < 45 bpm, systolic blood pressure <90 mm Hg, or has 
consumed caffeine within the last 12 hours. 
8. Subject has an acute psychiatric disorder. 
9. Subject is unwilling to comply with the requirements of the protocol. 
10. Subject has previously entered this study. 
11. Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used 
in this study. 
12. Subject suffers from claustrophobia. 
13. Subject has impaired renal function (creatinine > 1.5 mg/dl). 
14. Subject is in unstable condition. 
15. ST-elevations, new transient ST changes greater than 0.05mV or T- wave inversions with 
symptoms 
16. Subject cannot safely be administered Lexiscan™ per prescribing information as 
determined by investigator  
17. Subject has received interventional (PCI, stenting) or surgical (CABG) treatment that may 
alter the cardiac condition regarding myocardial perfusion status and/or stenosis degree 
between cardiac CTA, SPECT, MRI, and/or CT stress perfusion studies. 
 


 
14 
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Patients with heart rates >65 bpm may receive beta-blockers in order to lower the heart rate to 
values <60 bpm. Patients with contraindications to the use of beta-blockers (chronic obstructive 
pulmonary disease, asthma sensitive to beta agonists, second- or third-degree heart block, 
hypotension (<100 mm Hg systolic) are in principle eligible for participation in the study – however, 
no beta-blockers will be used in such individuals. 
 
There will not be any eligibility criteria for any subpopulations. In addition, there will not be any 
targeted involvement of special classes of subjects, such as fetuses, neonates, pregnant women, 
children, prisoners, institutionalized individuals, or others who may be considered vulnerable 
populations. All race and ethnicities and both genders will be considered for inclusion into the study. 
Subjects under the age of 18 will not be considered for inclusion into this study.  This research will 
only be conducted at the Medical University of South Carolina. 
 
Targeted/Planned Enrollment Table 
 
Total Planned Enrollment: 100 
 
TARGETED/PLANNED ENROLLMENT: Number of Subjects 
Ethnic Category 
Sex/Gender 
Females 
Males 
Total 
Hispanic or Latino 
0 
0 
0 
Not Hispanic or Latino 
50 
50 
100 
Ethnic Category: Total of All Subjects* 
100 
Racial Categories 
 
American Indian/Alaska Native 
0 
0 
0 
Asian 
0 
0 
0 
Native Hawaiian or Other Pacific Islander 
0 
0 
0 
Black or African American 
17 
17 
34 
White 
33 
33 
66 
Racial Categories: Total of All Subjects* 
50 
50 
100 
 
 
E.1.b Sources of Materials 
The research materials that will be obtained from living human subjects are: the cardiac SPECT, MRI 
stress perfusion, coronary catheterization, CT, and all applicable other imaging studies (e.g. 
echocardiography), progress notes, medication records, vital signs, medical history and 
demographics, and all other applicable clinical information.   
 
The Principal Investigator, Sub-Investigator(s) and the Study Coordinator(s) will be the only personnel 
who will have access to subject identities, with the exception of any regulatory personnel (MUSC IRB 
auditors, etc.). All subject identities will be removed prior to publication. 
 
E.1.c Potential Risks 
Patient discomfort  


 
15 
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The study prolongs the discomfort for the patient of lying supine by approximately 30 minutes for 
the CT study. Subjects may find it uncomfortable to lie still during the scans. A study duration of no 
more than 60 minutes room time will be used to minimize this discomfort. 
 
Vein puncture 
Patients could experience bruising, pain, and rare incidence of infection at the vein puncture site. 
This is like a blood test. This puncture is used to inject the contrast agents. Care will be taken to avoid 
these possible risks. Skin or vein irritation, fainting, blood clot formation, bleeding at the injection 
site, or an infection could also occur. 
 
Adverse reactions caused by iodinated contrast media 
Despite excluding patients with known history of allergy to iodinated contrast material, there is a 
small risk that a patient will have an allergic reaction to contrast medium. In this event, the physician 
supervising the scan acquisition in the study will administer appropriate care.  
 
In patients with pre-existing renal dysfunction, iodinated contrast material may cause further 
deterioration in renal function. Therefore, patients with decreased renal function (more than or 
equal to 1.50 mg/dl serum creatinine) will be excluded from this study. Large cohort studies and a 
recent meta-analysis have consistently demonstrated that there is no significant risk for post-
contrast nephropathy from intravenous contrast material in patients with normal renal function.24-26  
 
Radiation exposure 
The study-related CTMPI examination exposes the patient to additional ionizing radiation.  There is a 
small stochastic risk of radiation-induced cancer from this additional radiation exposure.  The 
population of patients undergoing cardiac imaging tests at our institution consists primarily of adults 
>50 years of age that have significant cardiovascular risk factors. In this population, the risk of 
radiation-induced cancer from cardiac CT has been estimated to be in the order of 1-in-2,000 
individuals.29 Since the radiation dose with the new CT system is expected to be substantially lower, 
the risk is likely to be even smaller. In particular, the novel scanner is equipped with a novel selective 
photon shield, which is expected to decrease radiation dose in particular for perfusion studies; this is 
discussed in more detail in section E of the supporting document attached to this application.  
 
Contrast and Drug Management 
The clinical stock of contrast will be used for this study and will be labeled with study specific 
identifiers tracking the administration and supply. The warmer located in the dual source CT scanner 
suite will be used to keep the study contrast at required temperature and contrast will not be kept 
longer than 30 days in the warmer per MUSC policy.  The records maintained for the contrast 
warmer and contrast supply are: temperature, supply of contrast, and contrast bottle used for each 
patient.  
 
Drugs will be ordered and dispensed from the MUSC inpatient pharmacy per clinical protocol. 
 
Risks from Contrast Media Extravasation 


 
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Although extremely rare, it is possible that an IV needle is not properly located within the vein or 
becomes dislodged when the patient lies down on the examination table. When contrast material is 
injected, it may then leak into the surrounding tissue. This can be painful and in very few instances 
has been reported to cause pressure on underlying nerves or vessels that needs to be surgically 
relieved. Usually, however, a contrast media extravasation is noticed early on by the personnel 
monitoring the procedure. However, even if a full dose of contrast material is injected in the tissue 
surrounding a vein, permanent damage is extremely unlikely. Usually the contrast material is fully 
absorbed by the body within a day without any harmful effect. In addition, in our department we use 
the latest automated contrast media injector generation, which also comprises of an automated 
extravasation detection device attached to the arm of the patient. Since the implementation of this 
device we have not experienced any major extravasation of contrast material. 
 
Beta Blocker (Lopressor) 
Common side effects of the drug Metoprolol (a Beta-Blocker) used to slow down the heart rate are: 
depression, diarrhea, dizziness, itching, rash, shortness of breath, slow heartbeat, and tiredness. Rare 
side effects are: blurred vision, cold hands and feet, confusion, congestive heart failure (ineffective 
pumping of the heart leading to an accumulation of fluid in the lungs), constipation, difficult or 
labored breath. 
 
Nitrate (Nitroglycerine) 
Common side effects of the drug Nitroglycerine (a Nitrate available in 0.4 mg or 0.8 mg for sublingual 
(under the tongue) administration include headache which may be severe and persistent and may 
occur immediately after use. Vertigo, dizziness, weakness, palpitation (irregular beatings of the 
heart), and other symptoms of postural hypotension (low blood pressure) may develop occasionally, 
particularly in upright, motionless subjects. Fainting, which may lead to falls and injuries has also 
been reported. Flushing, drug rash, and flaky skin have been reported in subjects receiving nitrate 
therapy. 
 
Use of Regadenoson  
The following reactions are listed as warnings and precautions when using regadenoson (Lexiscan™, 
injected as a 0.4 mg bolus): myocardial ischemia, sinoatrial and atrioventricular nodal block, 
hypotension, and bronchoconstriction. The following adverse reactions associated with regadenoson 
are considered transient and are listed in the package insert: dyspnea or urge to breathe deeply, 
headache, flushing, chest discomfort, angina pectoris or ST segment depression, 
lightheadedness/dizziness, chest pain, nausea, abdominal discomfort, impaired taste, and feeling 
hot. Dyspnea can occur during stress myocardial perfusion imaging with associated arrhythmias such 
as hypoxia induced bundle branch block. The first signs of these rare side effects will cause the 
termination of the examination. 
 
CT Examination performed with the new Force scanner 
The Siemens SOMATOM™ Force is a new computed Tomography X-ray system, which is substantially 
equivalent to the previous systems (SOMATOM™ Definition and the SOMATOM™ Definition Flash). 
The SOMATOM™ Force scanner received 510(k) FDA-approval for clinical use on the 17th April 2014. 


 
17 
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The SOMATOM™ Force scanner has been used for two other research studies with excellent results. 
The risks associated with this CT scanner are comparably low to other CT scanners. 
 
Acquisition of patient information 
The risks associated with gathering this information are believed to be very low. This information will 
be stored on a password-protected computer and network server and in a locked office (ART Cardiac 
Imaging Research Office). The data from this study will be accessible only to the team of researchers 
from this application. 
 
E.2   ADEQUACY OF PROTECTION AGAINST RISKS  
E.2.a   Recruitment and Informed Consent 
 
Patients who have been referred for a coronary CTA performed as part of a standard clinical 
evaluation determined by the treating physician(s) will be eligible for the study and recruited from 
the MUSC CT schedule. Before the patient comes in for their clinical coronary CTA, their cardiologist 
or primary physician will be contacted to ensure patient interest in the study and willingness to be 
approached. Willing patients will be approached and will undergo the informed consent process. 
Consented subjects will first undergo their clinically indicated coronary CTA; if there is no moderate 
or significant stenosis on the CTA following an initial interpretation (i.e., normal or near-normal 
coronary arteries), the patient will not undergo the stress CT perfusion portion of the study and will 
have their usual care without further testing for cardiac ischemia.  However, these patients will be 
included in the data analysis, belonging to the negative CT population. Patients with moderate, 
indeterminate, or significant stenosis of any major or large branch epicardial vessel on the CTA will 
then undergo the stress CT perfusion study. According to current guidelines, it is to be expected that 
this group of patients will also be clinically referred for further ischemia workup with either SPECT or 
coronary catheter angiography. 
 
We will also target patients who have undergone SPECT without referral for cardiac CTA; in this case, 
the coronary CT at rest will be performed as a research procedure with the stress portion following in 
all cases. The CT perfusion scans will be analyzed and read by two highly trained CT readers 
(cardiologist and radiologist).  In addition to assessing the safety and tolerability of the Lexiscan™ 
perfusion study, the CT perfusion findings will be compared diagnostically to SPECT and/or invasive 
catheter angiography if this is performed clinically after the research procedure. These patients must 
have the clinically indicated SPECT as well as the research cardiac CTA with CT perfusion study 
completed within 60 days. 
 
 
Patients who have undergone SPECT with a prior cardiac CTA will also be eligible for this study. These 
patients will only undergo the stress portion of CT perfusion study. These patients must have the 
clinically indicated cardiac CTA and SPECT as well as the research CT perfusion study completed 
within 60 days. 
 
Patients who have undergone MRI perfusion imaging without referral for cardiac CTA will also be 
eligible for this study. For these patients, the coronary CT at rest will be performed as a research 


 
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procedure followed by the stress portion of the CT perfusion study. No interpretation will be 
performed before the stress portion of the exam so all of these patients will receive the stress 
portion of the exam. These patients must have the clinically indicated MRI stress perfusion imaging 
as well as the research cardiac CTA with CT perfusion study completed within 60 days. 
 
Patients who have undergone MRI stress perfusion imaging with a prior cardiac CTA will also be 
eligible for this study. These patients will only undergo the stress portion of CT perfusion study. 
These patients must have the clinically indicated cardiac CTA and SPECT as well as the research CT 
perfusion study completed within 60 days. 
 
Only patients with initially negative biomarkers and non-specific-ECG findings will be considered for 
inclusion in the study in accordance with the Lexiscan package insert.  Patients will be screened by 
approved study personnel from the MUSC SPECT and CT schedules under a HIPAA waiver.  Study 
eligibility determination and study enrollment will be assessed and performed by and investigator in 
concert with a study coordinator delegated by the PI and approved by the IRB as being authorized to 
obtain informed consent. The potential use of Lexiscan™ and beta-blockers will be discussed with the 
responsible physician of record, potential contraindications will be ruled out and permission to 
approach the patient for possible inclusion will be sought.  If the patient is agreeable, they will be 
approached by one of the licensed physician investigators or designated study coordinators listed on 
the protocol either prior to or on the day of the CT scan, with a full explanation and request for 
consent as required by the IRB.  MUSC policies regarding patient consent will be followed. 
 
The PI, Sub-I(s) or the SC(s) will obtain informed consent prior to enrollment into the study. The 
subject will be taken to a quiet/private area (which may include the scanning room, the patient bays 
or other private areas) and the study purpose, procedures, duration, risks/discomforts, benefits, 
costs, compensation, alternatives, new information procedures and privacy statements will be 
explained to the subject. 
 
The subject will be asked to verbally repeat pertinent study information to ensure subject 
understands the nature of the research. Subjects will be provided the opportunity to ask any 
questions they may have. Consent will be documented in the currently IRB approved version of the 
informed consent and will be signed and dated by the person obtaining informed consent and the 
subject. 
 
E.2.b  Protection against Risk 
To minimize the risk of post-contrast nephropathy, patients with decreased renal function (creatinine 
>1.5 mg/dL) will not be eligible for this study. To minimize the risk of allergic reactions to iodinated 
contrast material, patients with a history of allergic reactions to iodinated contrast material will also 
be excluded.  
 
Clinical procedures involving Lexiscan™ administration in the Radiology department will be followed:  
Lexiscan™ administration will be supervised by a licensed cardiologist who will review the patient’s 
medication and medical history for contraindications before the scan, read the patient’s pre-scan 
EKG, be present for Lexiscan™ administration, read the patient’s post-scan EKG, and approve the 


 
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patient’s discharge from the Radiology department. Cardiac resuscitation equipment will be available 
throughout the scan.  
 
All subjects’ medical records will be confined in the usual medical health information office according 
to their policies and procedures. Each staff member that has approved access to electronic medical 
records will be given their own password and will be instructed not to reveal that password to 
anyone else. In addition, those copies of subject information utilized for the research protocol will be 
kept locked in the Radiology Research suite (ART 2244) in a research specific folder that will identify 
the subject on the outside of the folder only by initials, subject code (subsequent subject identifiers, 
i.e. 001, 002, 003, etc., this number will not be able to identify the subject), protocol name, and IRB 
study number (Pro #). Any data that are used in publication, analyses, etc. will not identify the 
subject by name, etc. Subjects will be monitored in clinic as per clinical standard practice for any 
possible side effects and treated as indicated. 
 
E.3  
POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND OTHERS 
Since the examinations in this study are performed for research purposes and are not used for 
diagnostic purposes, there are no direct benefits for study participants. However, the knowledge 
gained from this study may benefit future patients undergoing CT myocardial perfusion imaging. 
Substantial reductions in radiation dose are expected with the new CT systems. Considering that 
ionizing radiation is thought to carry a small stochastic risk of inducing cancer, the dose reduction 
further reduces this theoretical risk. Furthermore, because of the higher attenuation of iodine at low 
photon energies, the novel CT system can be expected to substantially decrease the amount of 
contrast material required for CT cardiac perfusion examinations. The small risk of compromising 
renal function by administration of iodinated contrast material in patients with preexisting renal 
disease can thus be further minimized. 
 
E. 4  IMPORTANCE OF THE KNOWLEDGE TO BE GAINED 
Knowledge gained during this study will enable an appreciation of the diagnostic accuracy of Ct 
cardiac perfusion imaging in comparison SPECT and invasive angiography for diagnosis of acute chest 
pain and give indications of potential impacts on clinical and diagnostic pathways. 
 
Furthermore, data from this study may potentially allow for substantial reductions in radiation dose 
and contrast material volume of CT examinations with new CT systems thus further minimizing the 
small risks of radiation-induced cancer and post-contrast nephropathy. Furthermore, the diagnostic 
value of CT imaging in detection coronary stenosis may be improved. 
 
E.5  
SUBJECT SAFETY AND MINIMIZING RISKS (DATA AND SAFETY MONITORING PLAN) 
Eligibility in each case will be confirmed by a named investigator. The source data will be collected by 
an independent technician and/or study coordinator, maintained securely by the PI and checked by 
the named investigators. Clinical data will be recorded on a Case Report Form (CRF). However, formal 
monitoring of site records will not be completed as part of the general conduct of the study. Data 
collected will be authentic, accurate and complete and the study will be conducted in accordance 
with the currently approved protocol (and any future approved amendments), Good Clinical 
Practiced (GCP) and all applicable regulatory requirements.   


 
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Any event meeting the criteria of an unanticipated problem involving risks to subjects or others will 
be reported to the MUSC IRB, as required by HRPP 4.7- Unanticipated Problems and Adverse Events 
Policy and Procedures. Clinical data will not be monitored by a 3rd party (i.e. Contract Research 
Organization) or sponsor but the results of the study will be written as a paper and may be submitted 
as abstracts to various conferences. Every effort will be made to ensure patient safety and 
confidentiality.  
 
F. FACILITIES AVAILABLE 
The Radiology department on the 2nd floor of the Ashley River Tower houses the SOMATOM™ Force 
on which the myocardial CT perfusion scan will occur. Nursing and physician preparation and 
monitoring of the patient, including EKG reading and the serum creatinine test, will occur in the 
patient bays of the Radiology department.   
Cardiac catheterization will occur clinically in the Heart and Vascular Center on the 3rd floor of the 
Ashley River Tower. Clinical SPECT imaging will occur on the 1st floor of the Ashley River Tower. 
Clinical CTA imaging will occur either in the Radiology department on the 2nd floor of the Ashley River 
Tower or in the Radiology Department of the MUSC Main Hospital.  
 
G. APPENDIX 
The patient satisfaction survey is as follows:  
Patient Satisfaction Survey (SPECT/MRI Stress 
Perfusion) 
How easy or difficult did you find 
the SPECT or MRI stress 
perfusion procedure? 
(1) Very Easy 
(2) Easy 
(3) Difficult 
(4) Very Difficult 
How do you feel about the length 
of the SPECT or MRI stress 
perfusion procedure? 
(1) Very Short 
(2) Short 
(3) Long 
(4) Very Long 
How much discomfort did you 
experience during the SPECT or 
MRI stress perfusion procedure? 
(1) No Discomfort 
(2) Some Discomfort 
(3) Moderate Discomfort 
(4) A Lot of Discomfort 


 
21 
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How nervous were you before 
and during the SPECT or MRI 
stress perfusion procedure? 
(1) Not Nervous 
(2) Somewhat Nervous 
(3) Moderately Nervous 
(4) Very Nervous 
How well do you feel that you 
understand the SPECT or MRI 
stress perfusion procedure? 
(1) Very Much Understand 
(2) Moderately Understand 
(3) Somewhat Understand 
(4) Don’t Understand  
How well do you feel that you 
understand the results of the 
procedure? 
(1) Very Much Understand 
(2) Moderately Understand 
(3) Somewhat Understand 
(4) Don’t Understand  
How willing would you be to 
undergo the SPECT or MRI 
stress perfusion procedure 
again? 
(1) Very Willing 
(2) Somewhat Willing 
(3) Somewhat Unwilling 
(4) Not at All Willing 
 
Patient Satisfaction Survey (CT Perfusion Scan) 
How easy or difficult did you find 
the CT Perfusion Scan 
procedure? 
(1) Very Easy 
(2) Easy 
(3) Difficult 
(4) Very Difficult 
How do you feel about the length 
of the CT Perfusion Scan 
procedure? 
(1) Very Short 
(2) Short 
(3) Long 
(4) Very Long 
How much discomfort did you 
experience during the CT 
Perfusion Scan procedure? 
(1) No Discomfort 
(2) Some Discomfort 
(3) Moderate Discomfort 
(4) A Lot of Discomfort 


 
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How nervous were you before 
and during the CT Perfusion 
Scan procedure? 
(1) Not Nervous 
(2) Somewhat Nervous 
(3) Moderately Nervous 
(4) Very Nervous 
How well do you feel that you 
understand the CT Perfusion 
Scan procedure? 
(1) Very Much Understand 
(2) Moderately Understand 
(3) Somewhat Understand 
(4) Don’t Understand  
How well do you feel that you 
understand the results of the 
procedure? 
(1) Very Much Understand 
(2) Moderately Understand 
(3) Somewhat Understand 
(4) Don’t Understand  
How willing would you be to 
undergo the CT Perfusion Scan 
procedure again? 
(1) Very Willing 
(2) Somewhat Willing 
(3) Somewhat Unwilling 
(4) Not at All Willing 
 
 
 
 
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