CT Myocardial Perfusion Imaging to Guide the Diagnosis and Treatment of Patients With Stable Coronary Artery Disease: a Randomized Controlled Study (POTENTIAL)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Treatment Decision, Coronary Artery Disease
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Enrollment
- 660
- Locations
- 4
- Primary Endpoint
- The rate of non-revascularization treatment of the two arms
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Bin Lu
Director of Radiologic Imaging
Chinese Academy of Medical Sciences, Fuwai Hospital
Eligibility 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
Outcomes
Primary Outcomes
The rate of non-revascularization treatment of the two arms
Time Frame: 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 Outcomes
- The rate of major adverse cardiovascular events of the two arms(One year after CT-MPI or SPECT-MPI)
- Difference in quality of Life of the two arms(One year after CT-MPI or SPECT-MPI)
- Difference in cost of the two arms(One year after CT-MPI or SPECT-MPI)
- 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)