Coronary Heart DiseaseSPECTMBFNCT02280941

Cadmium-zinc-telluride (CZT) Imaging of Myocardial Blood Flow (MBF) (SPECT MBF)

A study testing single photon emission computed tomography in people with Coronary Heart Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Coronary Heart Disease
What is being tested?: single photon emission computed tomography
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteCanada
Study dates: 30 Oct 2014to 2 Sep 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7

Other trials in Canada

About this study

Official title: Comparison of Myocardial Blood Flow Measurements With Dedicated Solid State SPECT Camera Imaging and 99mTc-Tetrofosmin Versus PET Imaging and Rubidium-82

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.

Read the 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.

Conditions: Coronary Heart Disease
Being tested: single photon emission computed tomography
Medical subject headings: Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

single photon emission computed tomographyOther
Single photon emission computed tomography (SPECT) imaging will be done.

Study groups in NCT02280941
Study group	Role	What they receive
Single photon emission computed tomography	Experimental	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. Receives: Other: single photon emission computed tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference Between Measurements of Myocardial Blood Flow Measured With PET and With SPECT
PET studies were acquired with either 82Rb or 13N-ammonia according to clinical protocol. The activity injected at both rest and stress was 10 MBq/kg (82Rb) or 5MBq/kg (ammonia). MBF was based on data acquired over 8 min (82Rb) or 4 min (ammonia). SPECT rest images were obtained for 11 min starting immediately before injection of 316 +/- 71 MBq of 99mTc-tetrofosmin. The patient returned at 45 min after injection for a 5 min static resting acquisition (corresponding to the standard time for myocardial perfusion imaging). Without repositioning, the patient was stressed using dipyridamole (0.14mg/kg/min for 5 minutes) with 11 minutes of list mode data acquired starting immediately before the injection of 1122 +/- 170 MBq of tetrofosmin. Both rest and stress injections were delivered mechanically over 30 seconds. A standard set of stress perfusion images were acquired at 45 mins after tracer injection. The myocardial blood flow obtained using SPECT was compared to the patient's PET.
Measured: From enrollment to completion of imaging was a maximum of four weeks. The average difference in acquisition dates was 19 +/- 9 days.
Precision of Myocardial Blood Flow Measurements Between Two SPECT Scans
SPECT myocardial blood flow (MBF) was measured and repeated at a mean interval of 18 days to assess precision of MBF measurements between the two scans.
Measured: From enrollment to completion of imaging was a maximum of four weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 20142 Sep 2022

First posted3 Nov 2014 (estimated)
Study start30 Oct 2014
Primary completion2 Sep 2022
Study completion2 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02280941
Sponsor's protocol ID: 20140589
Acronym: SPECTMBF
Status last verified: Jan 2025
First submitted: 7 Oct 2014
Last updated: 6 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 28611245
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.
PubMed 32026329
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.
PubMed 32069116

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Myocardial Blood Flow Measurements With Dedicated Solid State SPECT Camera Imaging and 99mTc-Tetrofosmin Versus PET Imaging and Rubidium-82
ClinicalTrials.gov ID: NCT02280941
Acronym / sponsor ID: SPECTMBF / 20140589
Conditions: Coronary Heart Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Ottawa Heart Institute Research CorporationUniversity, hospital or other
Collaborators: GE Healthcare
Study start: 30 Oct 2014 (actual)
Primary completion: 2 Sep 2022 (actual)
Study completion: 2 Sep 2022 (actual)
First posted: 3 Nov 2014 (estimated)
Results: Posted 6 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single photon emission computed tomography	Experimental	Other: single photon emission computed tomographyMyocardial 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
single photon emission computed tomographySingle photon emission computed tomography (SPECT) imaging will be done.	Other	Single photon emission computed tomography

Primary outcome

Difference Between Measurements of Myocardial Blood Flow Measured With PET and With SPECT
Time frame: From enrollment to completion of imaging was a maximum of four weeks. The average difference in acquisition dates was 19 +/- 9 days.
PET studies were acquired with either 82Rb or 13N-ammonia according to clinical protocol. The activity injected at both rest and stress was 10 MBq/kg (82Rb) or 5MBq/kg (ammonia). MBF was based on data acquired over 8 min (82Rb) or 4 min (ammonia). SPECT rest images were obtained for 11 min starting immediately before injection of 316 +/- 71 MBq of 99mTc-tetrofosmin. The patient returned at 45 min after injection for a 5 min static resting acquisition (corresponding to the standard time for myocardial perfusion imaging). Without repositioning, the patient was stressed using dipyridamole (0.14mg/kg/min for 5 minutes) with 11 minutes of list mode data acquired starting immediately before the injection of 1122 +/- 170 MBq of tetrofosmin. Both rest and stress injections were delivered mechanically over 30 seconds. A standard set of stress perfusion images were acquired at 45 mins after tracer injection. The myocardial blood flow obtained using SPECT was compared to the patient's PET.
Precision of Myocardial Blood Flow Measurements Between Two SPECT Scans
Time frame: From enrollment to completion of imaging was a maximum of four weeks.
SPECT myocardial blood flow (MBF) was measured and repeated at a mean interval of 18 days to assess precision of MBF measurements between the two scans.

Results and safety

Results posted to the registry on 6 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Photon Emission Computed Tomography	32	31

Primary outcome: Difference Between Measurements of Myocardial Blood Flow Measured With PET and With SPECT

Time frame: From enrollment to completion of imaging was a maximum of four weeks. The average difference in acquisition dates was 19 +/- 9 days.. Mean (Standard Deviation). Unit: mean residual difference in MBF

Measure	Comparision of Myocardial Blood Flow Between PET to SPECT Myocardial Perfusion Imaging. n = 31
Value	0.06 (0.37)

Population analysed: Patients with known coronary artery disease who underwent both PET and SPECT myocardial perfusion imaging within 4 weeks.

Primary outcome: Precision of Myocardial Blood Flow Measurements Between Two SPECT Scans

Time frame: From enrollment to completion of imaging was a maximum of four weeks.. Mean (Standard Deviation). Unit: % difference in MBF between SPECT scans

Measure	Comparison of Myocardial Blood Flow Measurements Between Two SPECT Scans. n = 30
Value	29.5 (1.5)

Population analysed: Patients scheduled for clinically indicated SPECT myocardial perfusion studies who had an intermediate to high pretest probability of disease were 18 years of age or older and had a BMI \< 40kg/m2 were recruited to the study.

Adverse events

Time frame: From enrollment to completion of patient imaging was four weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Difference Between Measurements of Myocardial Blood Flow Measured With PET and With SPECT	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28611245Wells 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.
Results publication: PubMed 32026329Do 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.
Results publication: PubMed 32069116Wells 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Terrence Ruddy, MD principal investigator

Ottawa Heart Institute Research Corporation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing single photon emission computed tomography in people with Coronary Heart Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference Between Measurements of Myocardial Blood Flow Measured With PET and With SPECT (time frame: From enrollment to completion of imaging was a maximum of four weeks. The average difference in acquisition dates was 19 +/- 9 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02280941, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.