CT Myocardial Perfusion to Guide the Diagnosis and Treatment of Patients With Stable Coronary Artery Disease (POTENTIAL)

Study Overview
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Brief Summary
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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
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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.

Official Title
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CT Myocardial Perfusion Imaging to Guide the Diagnosis and Treatment of Patients With Stable Coronary Artery Disease: a Randomized Controlled Study (POTENTIAL)

Conditions
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Treatment Decision, Coronary Artery Disease

Intervention / Treatment
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* Procedure: Invasive coronary angiography
* Other: routine medical treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-MPI guided without myocardial ischemia<br>There was no evidence of myocardial ischemia in patients with coronary heart disease by CT-MPI | Other: routine medical treatment<br>* Patients with negative myocardial ischemia either in CT-MPI guided arm or SPECT-MPI guided arm will scheduled to have routine medical therapy instead of invasive coronary angiography.<br>|
| Experimental: CT-MPI guided with myocardial ischemia<br>There was positive evidence of myocardial ischemia in patients with coronary heart disease by CT-MPI | Procedure: Invasive coronary angiography<br>* Patients with positive myocardial ischemia either in CT-MPI guided arm or SPECT-MPI guided arm will scheduled to undergo invasive coronary angiography.<br>|
| Active Comparator: SPECT-MPI guided without myocardial ischemia<br>There was no evidence of myocardial ischemia in patients with coronary heart disease by SPECT-MPI | Other: routine medical treatment<br>* Patients with negative myocardial ischemia either in CT-MPI guided arm or SPECT-MPI guided arm will scheduled to have routine medical therapy instead of invasive coronary angiography.<br>|
| Active Comparator: SPECT-MPI guided with myocardial ischemia<br>There was positive evidence of myocardial ischemia in patients with coronary heart disease by SPECT-MPI | Procedure: Invasive coronary angiography<br>* Patients with positive myocardial ischemia either in CT-MPI guided arm or SPECT-MPI guided arm will scheduled to undergo invasive coronary angiography.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of non-revascularization treatment of the two arms | The incidence of conventional angiography not leading to revascularization within 90 days after CT-MPI or SPECT-MPI. | within 90 days after CT-MPI or SPECT-MPI examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of major adverse cardiovascular events of the two arms | The composition of all-cause death, non-fatal myocardial infarction, stroke, revascularization, and hospital admissions for unstable angina. | One year after CT-MPI or SPECT-MPI | 
| Difference in quality of Life of the two arms | The Seattle Angina Questionnaire | One year after CT-MPI or SPECT-MPI | 
| Difference in cost of the two arms | Total clinical cost | One year after CT-MPI or SPECT-MPI | 
| Difference in cumulative radiation exposure dose of the two arms | Total cumulative radiation exposure dose | Total cumulative radiation exposure dose during CT-MPI or SPECT-MPI and invasive coronary angiography within one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT myocardial perfusion imaging, Coronary artery disease, clinical pathway, SPECT myocardial perfusion imaging