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

October 31, 2023 updated by: Bin Lu, Chinese Academy of Medical Sciences, Fuwai Hospital

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

660

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
        • Contact:
        • Contact:
    • Henan
      • Zhengzhou, Henan, China
        • Active, not recruiting
        • Fuwai Central China Cardiovascular Hospital
      • Zhengzhou, Henan, China
        • Active, not recruiting
        • The First Affiliated Hosptial of Zhengzhou University
    • Jilin
      • Changchun, Jilin, China
        • Active, not recruiting
        • The Second Norman Bethune Hospital of Jilin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: 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.
One year after CT-MPI or SPECT-MPI
Difference in quality of Life of the two arms
Time Frame: One year after CT-MPI or SPECT-MPI
The Seattle Angina Questionnaire
One year after CT-MPI or SPECT-MPI
Difference in cost of the two arms
Time Frame: One year after CT-MPI or SPECT-MPI
Total clinical cost
One year after CT-MPI or SPECT-MPI
Difference in cumulative radiation exposure dose of the two arms
Time Frame: Total cumulative radiation exposure dose during CT-MPI or SPECT-MPI and invasive coronary angiography within one year
Total cumulative radiation exposure dose
Total cumulative radiation exposure dose during CT-MPI or SPECT-MPI and invasive coronary angiography within one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 22, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-GSP-GG-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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