CT Myocardial Perfusion to Guide the Diagnosis and Treatment of Patients With Stable Coronary Artery Disease (POTENTIAL)
- Conditions
- Treatment Decision, Coronary Artery Disease
- Interventions
- Other: routine medical treatmentProcedure: Invasive coronary angiography
- Registration Number
- NCT06119022
- Lead Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Brief Summary
The overall goal of this project is to compare the non-revascularization rate of coronary angiography in patients with stable coronary artery disease (CAD) within 90 days after CT myocardial perfusion imaging (CT-MPI) or Single-Photon Emission Computed Tomography myocardial perfusion imaging (SPECT-MPI), and 1-year major adverse cardiovascular events (MACE).
- Detailed Description
Participants will be patients with proven coronary artery disease (CAD) who are scheduled randomized to undergo CT Myocardial Perfusion Imaging (CT-MPI) or Single-Photon Emission Computed Tomography myocardial perfusion imaging (SPECT-MPI) to evaluate myocardium ischemia. Those patients with positive myocardial ischemia will scheduled to undergo invasive coronary angiography (ICA), and those without myocardial ischemia will have optical medical therapy. The purpose of the study is to verify that CT-MPI guided clinical pathways are not inferior to SPECT-MPI pathways in downstream treatment decision making and safety assessment. In order to achieve this aim, the study team will compare the non-revascularization rate of ICA within 90 days after CT-MPI and SPECT-MPI. 1-year major adverse cardiovascular events (MACE) will be also compared.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 660
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CT-MPI guided without myocardial ischemia routine medical treatment There was no evidence of myocardial ischemia in patients with coronary heart disease by CT-MPI CT-MPI guided with myocardial ischemia Invasive coronary angiography There was positive evidence of myocardial ischemia in patients with coronary heart disease by CT-MPI SPECT-MPI guided without myocardial ischemia routine medical treatment There was no evidence of myocardial ischemia in patients with coronary heart disease by SPECT-MPI SPECT-MPI guided with myocardial ischemia Invasive coronary angiography There was positive evidence of myocardial ischemia in patients with coronary heart disease by SPECT-MPI
- Primary Outcome Measures
Name Time Method The rate of non-revascularization treatment of the two arms within 90 days after CT-MPI or SPECT-MPI examination The incidence of conventional angiography not leading to revascularization within 90 days after CT-MPI or SPECT-MPI.
- Secondary Outcome Measures
Name Time Method The rate of major adverse cardiovascular events of the two arms One year after CT-MPI or SPECT-MPI The composition of all-cause death, non-fatal myocardial infarction, stroke, revascularization, and hospital admissions for unstable angina.
Difference in quality of Life of the two arms One year after CT-MPI or SPECT-MPI The Seattle Angina Questionnaire
Difference in cost of the two arms One year after CT-MPI or SPECT-MPI Total clinical cost
Difference in cumulative radiation exposure dose of the two arms Total cumulative radiation exposure dose during CT-MPI or SPECT-MPI and invasive coronary angiography within one year Total cumulative radiation exposure dose
Trial Locations
- Locations (4)
Fuwai Central China Cardiovascular Hospital
🇨🇳Zhengzhou, Henan, China
Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
The Second Norman Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The First Affiliated Hosptial of Zhengzhou University
🇨🇳Zhengzhou, Henan, China