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

NCT ID: NCT06119022

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2025-12-31

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.

Conditions

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Treatment Decision, Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CT-MPI guided without myocardial ischemia

There was no evidence of myocardial ischemia in patients with coronary heart disease by CT-MPI

Group Type EXPERIMENTAL

routine medical treatment

Intervention Type OTHER

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.

CT-MPI guided with myocardial ischemia

There was positive evidence of myocardial ischemia in patients with coronary heart disease by CT-MPI

Group Type EXPERIMENTAL

Invasive coronary angiography

Intervention Type PROCEDURE

Patients with positive myocardial ischemia either in CT-MPI guided arm or SPECT-MPI guided arm will scheduled to undergo invasive coronary angiography.

SPECT-MPI guided without myocardial ischemia

There was no evidence of myocardial ischemia in patients with coronary heart disease by SPECT-MPI

Group Type ACTIVE_COMPARATOR

routine medical treatment

Intervention Type OTHER

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.

SPECT-MPI guided with myocardial ischemia

There was positive evidence of myocardial ischemia in patients with coronary heart disease by SPECT-MPI

Group Type ACTIVE_COMPARATOR

Invasive coronary angiography

Intervention Type PROCEDURE

Patients with positive myocardial ischemia either in CT-MPI guided arm or SPECT-MPI guided arm will scheduled to undergo invasive coronary angiography.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bin Lu

Director of Radiologic Imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

Site Status ACTIVE_NOT_RECRUITING

The First Affiliated Hosptial of Zhengzhou University

Zhengzhou, Henan, China

Site Status ACTIVE_NOT_RECRUITING

The Second Norman Bethune Hospital of Jilin University

Changchun, Jilin, China

Site Status ACTIVE_NOT_RECRUITING

Countries

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China

Central Contacts

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Yang Gao, M.D

Role: CONTACT

86-10-88322656

Facility Contacts

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Yang Gao, M.D

Role: primary

86-10-88322656

Qingchao Meng, M.D

Role: backup

86-10-88322658

Other Identifiers

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2023-GSP-GG-21

Identifier Type: -

Identifier Source: org_study_id

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