Clinical trial NCT02280941: Cadmium-zinc-telluride (CZT) Imaging of Myocardial Blood Flow (MBF) (SPECT MBF)
Official title: Comparison of Myocardial Blood Flow Measurements With Dedicated Solid State SPECT Camera Imaging and 99mTc-Tetrofosmin Versus PET Imaging and Rubidium-82
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2014-11-02
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to compare the blood flow measurements obtained with the SPECT and PET imaging scans. Measurements such as myocardial blood flow (MBF) and myocardial flow reserve (MFR) are analyzed on PET scans. These measurements give the doctors more precise information in diagnosing heart problems. SPECT scans, with new camera technology and computer software, now have the potential to also give this additional information. The study is investigating how well the blood flow measurements from SPECT compared to PET.

Detailed description: Absolute myocardial blood flow (MBF) and myocardial flow reserve (MFR) are calculated measurements that are obtained using positron emission tomography (PET) nuclear imaging, from a myocardial perfusion imaging (MPI) stress test, due to the advanced capabilities of the PET camera technology. These calculations provide more diagnostic and prognostic information for patients. Single photon emission computed tomography (SPECT) nuclear imaging is more widely done due to the availability and lower costs, but in the past has not been able to provide the additional information needed to perform the MBF and MFR calculations. SPECT cameras have now been developed and are in use, as well as software for the cameras that have shown that these measurements can be obtained from SPECT. The goal of this study is to compare SPECT and PET measurement of MBF and MFR and determine the reproducibility of SPECT MFR measurements.

The study will be done in 3 Phases, with recruitment done over 3 years. Phase 1 and 2 will be done over the first 2 years, with Phase 3 planned following Phases 1 and 2, in the 3rd year of recruitment.

Phase 1: patients with coronary artery disease, who are coming to the University of Ottawa Heart Institute (UOHI) for MPI stress testing will have both a PET and SPECT MPI for comparison of the measurements of MBF and MFR. The PET scan will be done as the clinical, reportable test.

Phase 2: patients with coronary artery disease, who are coming to UOHI for SPECT MPI testing will have the SPECT repeated to see how reproducible the measurements are.

Phase 3: normal, healthy volunteers will have both a PET and SPECT scan for the comparison of the measurements of MBF and MFR.

No change to any patient care will be done in Phases 1 and 2. Phase 1 and Phase 2 participants will have 1 research scan and Phase 3 participants will have 2 research scans.

Rubidium (Rb-82) Elution System Performance Data will be collected on the elution pump system, used to deliver the Rb-82 isotope, to support the system performance documentation for Health Canada Authorization.

Eligibility criteria: Inclusion Criteria:

For all participants

* Age ≥ 18 years old
* BMI ≤ 40 kg/m2
* Able and willing to comply with the study procedures
* Written informed consent Participants with intermediate to high probability of CAD
* Suspected or known CAD on a stable medication regime. Healthy volunteers without known heart disease
* Low risk of CAD (ACC Guidelines Pre-test Probability of Coronary Disease by Symptoms, Gender and Age)

Exclusion Criteria:

* History or risk of severe bradycardia (heart rate \< 50 beats per minute) not related to chronotropic drugs
* Known second- or third-degree AV block without pacemaker
* Dyspnea (NYHA III/IV), wheezing asthma or COPD
* Coronary artery bypass graft (CABG) surgery within 60 days prior to screening or at any time after consent
* Percutaneous coronary intervention (PCI) within 30 days prior to screening or at any time following consent
* Acute myocardial infarction or acute coronary syndrome within 60 days prior to screening or at any time following consent
* Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)
* Known hypersensitivity to dipyridamole
* Breastfeeding or pregnancy
* Claustrophobia or inability to lie still in a supine position
* Unwillingness or inability to provide informed consent

Primary outcomes:
measure: Difference Between Measurements of Myocardial Blood Flow Measured With PET and With SPECT
timeFrame: From enrollment to completion of imaging was a maximum of four weeks. The average difference in acquisition dates was 19 +/- 9 days.
measure: Precision of Myocardial Blood Flow Measurements Between Two SPECT Scans
timeFrame: From enrollment to completion of imaging was a maximum of four weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Terrence Ruddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wells RG, Marvin B, Poirier M, Renaud J, deKemp RA, Ruddy TD. Optimization of SPECT Measurement of Myocardial Blood Flow with Corrections for Attenuation, Motion, and Blood Binding Compared with PET. J Nucl Med. 2017 Dec;58(12):2013-2019. doi: 10.2967/jnumed.117.191049. Epub 2017 Jun 13.
citation: Do J, Ruddy TD, Wells RG. Reduced acquisition times for measurement of myocardial blood flow with 99mTc-tetrofosmin and solid-state detector SPECT. J Nucl Cardiol. 2021 Dec;28(6):2518-2529. doi: 10.1007/s12350-020-02048-w. Epub 2020 Feb 5.
citation: Wells RG, Radonjic I, Clackdoyle D, Do J, Marvin B, Carey C, deKemp RA, Ruddy TD. Test-Retest Precision of Myocardial Blood Flow Measurements With 99mTc-Tetrofosmin and Solid-State Detector Single Photon Emission Computed Tomography. Circ Cardiovasc Imaging. 2020 Feb;13(2):e009769. doi: 10.1161/CIRCIMAGING.119.009769. Epub 2020 Feb 11.