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

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06119022

Collaborator

(none)

660

Enrollment

Locations

Arms

Anticipated Duration (Months)

165

Patients Per Site

6.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Treatment Decision, Coronary Artery Disease	Procedure: Invasive coronary angiography Other: routine medical treatment	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

660 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 30, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences	Beijing	Beijing	China
2	Fuwai Central China Cardiovascular Hospital	Zhengzhou	Henan	China
3	The First Affiliated Hosptial of Zhengzhou University	Zhengzhou	Henan	China
4	The Second Norman Bethune Hospital of Jilin University	Changchun	Jilin	China