Cadmium-zinc-telluride (CZT) Imaging of Myocardial Blood Flow (MBF) (SPECT MBF) (SPECT MBF)
Primary Purpose
Coronary Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
single photon emission computed tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Heart Disease
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
Sites / Locations
- University of Ottawa Heart InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single photon emission computed tomography
Arm Description
Myocardial blood flow (MBF) measurement will be analyzed using attenuation and scatter corrected dynamic single photon emission computed tomography (SPECT) imaging data. The data will be compared to MBF obtained from positron emission tomography (PET) imaging.
Outcomes
Primary Outcome Measures
Correlation
The correlation of global and regional myocardial blood flow (MBF) measurements and calculated myocardial flow reserve (MFR) using single photon emission computed tomography (SPECT) and 99mTc-tetrofosmin (99mTc) to positron emission tomography (PET) and Rubidium-82 (Rb-82) will be determined.
Reproducibility
The reproducibility of global and regional myocardial blood flow (MBF) measurements and calculated myocardial flow reserve (MFR) using single photon emission computed tomography (SPECT) will be determined.
Secondary Outcome Measures
Full Information
NCT ID
NCT02280941
First Posted
October 7, 2014
Last Updated
March 30, 2021
Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
GE Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT02280941
Brief Title
Cadmium-zinc-telluride (CZT) Imaging of Myocardial Blood Flow (MBF) (SPECT MBF)
Acronym
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
GE Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single photon emission computed tomography
Arm Type
Experimental
Arm Description
Myocardial blood flow (MBF) measurement will be analyzed using attenuation and scatter corrected dynamic single photon emission computed tomography (SPECT) imaging data. The data will be compared to MBF obtained from positron emission tomography (PET) imaging.
Intervention Type
Other
Intervention Name(s)
single photon emission computed tomography
Intervention Description
Single photon emission computed tomography (SPECT) imaging will be done.
Primary Outcome Measure Information:
Title
Correlation
Description
The correlation of global and regional myocardial blood flow (MBF) measurements and calculated myocardial flow reserve (MFR) using single photon emission computed tomography (SPECT) and 99mTc-tetrofosmin (99mTc) to positron emission tomography (PET) and Rubidium-82 (Rb-82) will be determined.
Time Frame
3 years
Title
Reproducibility
Description
The reproducibility of global and regional myocardial blood flow (MBF) measurements and calculated myocardial flow reserve (MFR) using single photon emission computed tomography (SPECT) will be determined.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clare Carey, BScN
Phone
613-696-7000
Ext
15103
Email
CCarey@ottawaheart.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terrence Ruddy, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clare Carey, BScN
Phone
613-696-7000
Ext
15103
Email
CCarey@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Terrence Ruddy, MD
12. IPD Sharing Statement
Learn more about this trial
Cadmium-zinc-telluride (CZT) Imaging of Myocardial Blood Flow (MBF) (SPECT MBF)
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