Using CT Myocardial Perfusion Imaging to Guide Treatment in Stable Coronary Artery Disease
CT Myocardial Perfusion Imaging to Guide the Diagnosis and Treatment of Patients With Stable Coronary Artery Disease: a Randomized Controlled Study (POTENTIAL)
This study is testing whether using a special heart imaging technique called CT Myocardial Perfusion Imaging can help doctors make better treatment decisions for people with stable coronary artery disease compared to a different imaging method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 660 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 4 sites (Beijing, Beijing and 3 other locations) |
| Trial ID | NCT06119022 on ClinicalTrials.gov |
What this trial studies
This project aims to compare the effectiveness of CT Myocardial Perfusion Imaging (CT-MPI) versus Single-Photon Emission Computed Tomography (SPECT-MPI) in guiding treatment decisions for patients with stable coronary artery disease (CAD). Participants will be randomized to receive either imaging technique to evaluate myocardial ischemia, followed by invasive coronary angiography for those with positive results or medical therapy for those without. The study will assess the non-revascularization rates within 90 days and the occurrence of major adverse cardiovascular events (MACE) over one year. The goal is to determine if CT-MPI pathways are as effective as SPECT-MPI pathways in managing CAD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stable chest pain and significant coronary artery stenosis.
Not a fit: Patients with acute coronary syndrome, severe heart failure, or those requiring urgent procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective imaging strategy for guiding treatment decisions in patients with stable coronary artery disease.
How similar studies have performed: Previous studies have shown promising results with similar imaging approaches, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Patients with stable chest pain who have undergone coronary CT angiography and have 50-90% stenosis in at least one vessel \> 2mm in diameter * Able to provide signed informed consent Exclusion Criteria: * Suspected or confirmed acute coronary syndrome * Evidence of clinical instability or need for an emergent procedure * History of percutaneous coronary stent implantation, history of coronary artery bypass grafting, or history of myocardial infarction * Left main artery stenosis ≥ 50% * Severe heart failure (New York Heart Association (NYHA) ≥III) * Estimated glomerular filtration rate \< 60 mL/min/1.73 m2 * Contraindicated to use contrast agents, beta-blockers, nitrates or adenosine drugs * Acute episodes of bronchial asthma or chronic obstructive pulmonary disease * II or III degree atrioventricular block * History of pacemaker or implantable cardioverter defibrillator implantation * Combined with other cardiovascular diseases including cardiomyopathy, congenital heart disease, valvular heart disease, pulmonary vascular disease, pericardial disease, etc * Pregnant or trying to be pregnant * Combined with any other serious disease, life expectancy \<1 year * Any condition leading to possible inability to comply with the protocol procedures and follow-up * Currently participating in any other clinical trials
Where this trial is running
Beijing, Beijing and 3 other locations
- Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)
- Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China (Active_not_recruiting)
- The First Affiliated Hosptial of Zhengzhou University — Zhengzhou, Henan, China (Active_not_recruiting)
- The Second Norman Bethune Hospital of Jilin University — Changchun, Jilin, China (Active_not_recruiting)
Study contacts
- Study coordinator: Yang Gao, M.D
- Email: gaoyang226@126.com
- Phone: 86-10-88322656
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.