Clinical trial NCT02161081: A Study on Improved Dynamic Myocardial Perfusion With Less Effective Radiation Dose in CT (SIMPLE CT)
Official title: Adenosine-induced Stress Myocardial Perfusion Imaging With Dual-source 128-slice CT: a Study on the Comparison of Diagnostic Performance of Dynamic Scanning Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
Keywords: Myocardial ischemia
Coronary artery disease
Myocardial CT perfusion
Modified scan protocol
Diagnostic performance
Radiation dose
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2014-06-11
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Among the current myocardial CT perfusion techniques, dynamic CT perfusion technique is most advantageous in obtaining information on myocardial blood flow and volume. However, dynamic CT perfusion technique involves higher radiation dose than static CT techniques. Patients have to take a breath hold during 30 seconds with current dynamic CT perfusion protocol. If patients cannot hold their breath, anterior or inferior myocardium might be excluded due to limited scan coverage of a 128-slice dual-source CT scanner.

Reduction of scanning duration of dynamic CT perfusion may not only reduce radiation exposure, but also make patients more comfortable. Therefore, the investigators intended to propose a modified scan protocol with shorter scan duration and compare diagnostic accuracy of a modified scan protocol with the current scan protocol.

Detailed description: The aim of this study is to compare the diagnostic performance of adenosine-stress dynamic myocardial CT perfusion using a reduced dynamic scan duration with perfusion protocol of 30-second scan duration for the detection of myocardial perfusion defect and significant coronary artery stenosis.

This trial is a single center, prospective, randomized trial designed to compare diagnostic performances and radiation doses between two protocols with 30-second or 21-second dynamic scan durations. A total of 120 symptomatic patients will be randomized to dynamic CT perfusion protocols with 30-second or 21-second scan duration. They will also undergo 1.5-T MRI and invasive coronary angiography as reference standards for the assessment of myocardial perfusion and coronary artery stenosis. The primary end point of the study is to compare diagnostic performances between two CT protocols of dynamic CT perfusion. The secondary endpoint of this study is to compare radiation doses and image qualities of two scan protocols.

Eligibility criteria: Inclusion Criteria:

1. Men and women patients, with age ranging 30-80.
2. Known or suspected coronary artery disease who are supposed to undergo invasive coronary angiography
3. Patients who are willing to sign the informed consent form

Exclusion Criteria:

1. Contraindication of CT

   * Known allergy to iodinated contrast media or history of contrast-induced nephropathy
   * Decreased renal function: elevated serum creatinine (\>1.5 mg/dl)
   * Severe arrhythmia: atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block)
   * Severe thyroid disease
   * Homocystinuria
   * History of asthma
   * Hypersensitivity to adenosine
   * Severe obstructive lung disease
   * Intake of caffeine or xanthine-containing compounds within the last 48 hours
2. Contraindication of MRI

   * Claustrophobia
   * Metallic hazards
   * Pacemaker implant
   * eGFR (estimated glomerular filtration rate) \<30 ml/min
   * Clipping for aneurysm (stainless steel clips), neurostimulator, cochlear implant.
3. Unstable or uncooperative patients
4. Limited life expectancy due to cancer or end-stage renal or liver disease
5. Evidence of severe symptomatic heart failure (NYHA Class III or IV)
6. Acute myocardial infarction, hypertrophic cardiomyopathy, dilated cardiomyopathy, coronary artery bypass surgery, or other cardiac surgery
7. Women with positive pregnancy tests

Primary outcomes:
measure: AUC (area under the curve) of CT perfusion for detection of perfusion defects : 30-second scanning protocol versus 21-second scanning protocol
timeFrame: When all randomized patients underwent CT scanning (A total of 120 symptomatic patients will be randomized to dynamic CT perfusion protocols with 30-second or 21-second scan duration.)
Secondary outcomes:
measure: Effective radiation dose for each component of the CT examination is calculated as the product of the dose-length product multiplied by a conversion coefficient of 0.014 (mSv/[mGycm]).
timeFrame: up to 1 week after each patient underwent CT scanning
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yeon Hyeon Choe, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: