N/A
N=35
Multi-Center Evaluation of Feasibility of SPECT Measurement of Myocardial Blood Flow and Reserve
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT03427749 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Correlation in MBF Between Core Laboratory and Local Site — 0.93 correlation coefficient
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- SPECT Imaging with 99mTc-Tetrofosmin Research Imaging (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ottawa Heart Institute Research Corporation
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation in MBF Between Core Laboratory and Local Site |
0.93 | — |
| SECONDARY Impact on Throughput |
72.28 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
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 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)
- 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
Data sourced from ClinicalTrials.gov (NCT03427749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.