Using SPECT to Measure Blood Flow for Diagnosing Heart Disease
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
This study is trying to see if a special imaging test can better diagnose heart disease in people who might have it by measuring blood flow in the heart.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06030596 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the diagnostic accuracy for coronary artery disease (CAD) by quantifying myocardial blood flow (MBF) using single photon emission tomography (SPECT). It seeks to establish optimal cutoff values for absolute MBF and myocardial flow reserve (MFR) and validate these against fractional flow reserve (FFR) results. Patients with suspected or known CAD who are referred for invasive coronary angiography will be included in the study. The findings could enhance the diagnostic capabilities for CAD, particularly in determining hemodynamically significant cases.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 79 with at least one risk factor for CAD and a moderate to high likelihood of having the disease.
Not a fit: Patients with a history of severe bradycardia, myocardial infarction, or those who have undergone coronary interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of coronary artery disease, allowing for better-targeted treatments.
How similar studies have performed: Previous studies have shown promise in using SPECT for diagnosing CAD, but this specific approach of validating MBF and MFR against FFR is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 \~ 79 years old * At least one CAD risk factor * Intermediate to high pre-test likelihood for CAD * Suspected or known CAD, clinically referred for invasive coronary angiography * Able and willing to comply with the study procedures * Written informed consent Exclusion Criteria: * History or risk of severe bradycardia * History of myocardial infarction, dilated cardiomyopathy, hypertrophic cardiomyopathy, valve issue or congenital heart disease * Wheezing asthma or COPD * Known second- or third-degree AV block * Known hypersensitivity to dipyridamole or adenosine * Known coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) prior to screening * Breastfeeding or pregnancy * Claustrophobia or inability to lie still in a supine position * Unwillingness or inability to provide informed consent
Where this trial is running
Beijing, Beijing
- Fuwai Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Lei Wang, MD/PhD
- Email: leiwangfw@126.com
- Phone: 861088322728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.