Coronary Artery DiseaseNCT03427749
Multi-Center Evaluation of Feasibility of SPECT Measurement of Myocardial Blood Flow and Reserve
An observational study of Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 7 sites in 6 countries.
Trial summary
Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) ,who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- SPECT Imaging with 99mTc-Tetrofosmin Research Imaging
- Type of treatment
- Injection or infusion
- How many people
- 35 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 12 Oct 2018to 1 Oct 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be adult male and female patients who are referred to the outpatient cardiology clinics and/or the non-invasive Diagnostic Imaging Department at the local site, have known or suspected CAD and are deemed to clincally require MBF measurements.
Who may be able to join
- Age ≥ 18 years old
- BMI ≤ 40 kg/m2
- Able and willing to comply with the study procedures
- Written informed consent
- Intermediate to high probability of CAD
- Suspected or known CAD on a stable medication regime
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 within 45 days after consent (early revascularization)
- Percutaneous coronary intervention (PCI) within 30 days prior to screening or within 45 days following consent (early revascularization)
- Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)
Show all 10Show fewer
- Known hypersensitivity to dipyridamole or adenosine
- Breastfeeding or pregnancy
- Claustrophobia or inability to lie still in a supine position
- Unwillingness or inability to provide informed consent
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Canada2 sites
London Health Sciences Centre
London, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Italy1 site
Nuclear Medicine, Università & Spedali Civili, Brescia, Italy
Brescia
About this study
Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) ,who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study.
Read the detailed description
Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI), who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study. Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin. This is an observational study; patients will be managed according to the standard clinical care of the local site. Where available, a CT scan will also be acquired for attenuation and/or scatter correction. Studies may be one day (rest/stress or stress/rest) or two day (rest and stress on separate days) All studies will be analyzed locally but the raw data will also be anonymized and forwarded to the core facility for reprocessing. Central processing will allow comparison between sites and the repeat processing will provide an estimate of inter-operator variability in the measurements. The core lab will also compare the relative perfusion from immediate and delayed imaging for image quality and diagnostic accuracy (visual and quantitative).
- Conditions
- Coronary Artery Disease
- Being tested
- SPECT Imaging with 99mTc-Tetrofosmin Research Imaging
- Keywords
- Myocardial Blood Flow, SPECT
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT Imaging with 99mTc-Tetrofosmin Research ImagingDiagnostic test
This is an observational study; patients will be managed according to the standard clinical care of the local site. Study end will be defined as completion of all SPECT imaging at rest and stress. Studies will be acquired at 6 initial sites with mixed prior experience at MBF imaging, to demonstrate feasibility of use in a clinical setting.
| Study group | Role | What they receive |
|---|---|---|
| SPECT Imaging with 99mTc-Tetrofosmin | Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) and who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%). Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin Receives: Diagnostic Test: SPECT Imaging with 99mTc-Tetrofosmin Research Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation in MBF Between Core Laboratory and Local Site
MBF was measured locally and at a core laboratory using commercially available software. The acquisition protocol was standardized between the local site and core laboratory. a one-day rest-stress protocol was used. Relative perfusion images were obtained after tracer injection. All raw study data were transferred to the core laboratory where processing was independently repeated by one reader to evaluate inter site processing consistency. Perfusion scores were compared with the measured MBF.
Measured: The average total amount of time that the patient was assessed for the MBF protocol varied between 71 and 122 minutes.
Secondary outcomes (1)
Impact on Throughput
Additional acquisition time for the MBF acquisition. For each patient study, the time during which the patient was in the camera room for each imaging session was recorded along with the start times for each scan. From this data, the increase in time for MBF protocol compared with the time for a standard myocardial perfusion imaging protocol was determined.
Measured: The average total time the patient was in the camera room during the study protocol was 72.28 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start12 Oct 2018
- Primary completion1 Oct 2022
- Study completion1 Oct 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 (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Terrence Ruddy, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427749
- Sponsor's protocol ID
- 20170797
- Status last verified
- Aug 2024
- First submitted
- 2 Feb 2018
- Last updated
- 10 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wells RG, Bengel FM, Camoni L, Cerudelli E, Cuddy-Walsh SG, Diekmann J, Han L, Kadoya Y, Kawaguchi N, Keng YJF, Miyagawa M, Ratner H, Teng XF, Ruddy TD. Multicenter Evaluation of the Feasibility of Clinical Implementation of SPECT Myocardial Blood Flow Measurement: Intersite Variability and Imaging Time. Circ Cardiovasc Imaging. 2023 Oct;16(10):e015009. doi: 10.1161/CIRCIMAGING.122.015009. Epub 2023 Oct 6.
PubMed 37800325
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Evaluation of Feasibility of SPECT Measurement of Myocardial Blood Flow and Reserve
- ClinicalTrials.gov ID
- NCT03427749
- Acronym / sponsor ID
- 20170797
- Conditions
- Coronary Artery Disease
- Keywords
- Myocardial Blood Flow, SPECT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Posted 10 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) ,who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study.
Detailed description
Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI), who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study. Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin. This is an observational study; patients will be managed according to the standard clinical care of the local site. Where available, a CT scan will also be acquired for attenuation and/or scatter correction. Studies may be one day (rest/stress or stress/rest) or two day (rest and stress on separate days) All studies will be analyzed locally but the raw data will also be anonymized and forwarded to the core facility for reprocessing. Central processing will allow comparison between sites and the repeat processing will provide an estimate of inter-operator variability in the measurements. The core lab will also compare the relative perfusion from immediate and delayed imaging for image quality and diagnostic accuracy (visual and quantitative).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPECT Imaging with 99mTc-Tetrofosmin | – | Diagnostic Test: SPECT Imaging with 99mTc-Tetrofosmin Research ImagingPatients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) and who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%). Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be adult male and female patients who are referred to the outpatient cardiology clinics and/or the non-invasive Diagnostic Imaging Department at the local site, have known or suspected CAD and are deemed to clincally require MBF measurements.
Key inclusion criteria (6 listed)
- Age ≥ 18 years old
- BMI ≤ 40 kg/m2
- Able and willing to comply with the study procedures
- Written informed consent
- Intermediate to high probability of CAD
Key exclusion criteria (10 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 within 45 days after consent (early revascularization)
- Percutaneous coronary intervention (PCI) within 30 days prior to screening or within 45 days following consent (early revascularization)
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 |
|---|---|---|
| SPECT Imaging with 99mTc-Tetrofosmin Research ImagingThis is an observational study; patients will be managed according to the standard clinical care of the local site. Study end will be defined as completion of all SPECT imaging at rest and stress. Studies will be acquired at 6 initial sites with mixed prior experience at MBF imaging, to demonstrate feasibility of use in a clinical setting. | Diagnostic test | SPECT Imaging with 99mTc-Tetrofosmin |
Primary outcome
Correlation in MBF Between Core Laboratory and Local Site
Time frame: The average total amount of time that the patient was assessed for the MBF protocol varied between 71 and 122 minutes.
MBF was measured locally and at a core laboratory using commercially available software. The acquisition protocol was standardized between the local site and core laboratory. a one-day rest-stress protocol was used. Relative perfusion images were obtained after tracer injection. All raw study data were transferred to the core laboratory where processing was independently repeated by one reader to evaluate inter site processing consistency. Perfusion scores were compared with the measured MBF.
1 secondary outcome
Impact on Throughput
Time frame: The average total time the patient was in the camera room during the study protocol was 72.28 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37800325Wells RG, Bengel FM, Camoni L, Cerudelli E, Cuddy-Walsh SG, Diekmann J, Han L, Kadoya Y, Kawaguchi N, Keng YJF, Miyagawa M, Ratner H, Teng XF, Ruddy TD. Multicenter Evaluation of the Feasibility of Clinical Implementation of SPECT Myocardial Blood Flow Measurement: Intersite Variability and Imaging Time. Circ Cardiovasc Imaging. 2023 Oct;16(10):e015009. doi: 10.1161/CIRCIMAGING.122.015009. Epub 2023 Oct 6.
- 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
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 7 sites in 6 countries.
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 6 inclusion and 10 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 10 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 7 sites in Canada, Belgium, Germany, Italy, Japan and 1 more country. 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 10 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?
Correlation in MBF Between Core Laboratory and Local Site (time frame: The average total amount of time that the patient was assessed for the MBF protocol varied between 71 and 122 minutes.). 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 NCT03427749, which also lists 1 linked publication.
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 10 Apr 2025.