CT Myocardial Perfusion to Guide the Diagnosis and Treatment of Patients With Stable Coronary Artery Disease (POTENTIAL)
CT Myocardial Perfusion Imaging to Guide the Diagnosis and Treatment of Patients With Stable Coronary Artery Disease: a Randomized Controlled Study (POTENTIAL)
1 other identifier
interventional
660
1 country
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2023
CompletedFirst Submitted
Initial submission to the registry
October 22, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 7, 2023
October 1, 2023
1.3 years
October 22, 2023
October 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Study Arms (4)
CT-MPI guided without myocardial ischemia
EXPERIMENTALThere was no evidence of myocardial ischemia in patients with coronary heart disease by CT-MPI
CT-MPI guided with myocardial ischemia
EXPERIMENTALThere was positive evidence of myocardial ischemia in patients with coronary heart disease by CT-MPI
SPECT-MPI guided without myocardial ischemia
ACTIVE COMPARATORThere was no evidence of myocardial ischemia in patients with coronary heart disease by SPECT-MPI
SPECT-MPI guided with myocardial ischemia
ACTIVE COMPARATORThere was positive evidence of myocardial ischemia in patients with coronary heart disease by SPECT-MPI
Interventions
Patients with positive myocardial ischemia either in CT-MPI guided arm or SPECT-MPI guided arm will scheduled to undergo invasive coronary angiography.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
The First Affiliated Hosptial of Zhengzhou University
Zhengzhou, Henan, China
The Second Norman Bethune Hospital of Jilin University
Changchun, Jilin, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Radiologic Imaging
Study Record Dates
First Submitted
October 22, 2023
First Posted
November 7, 2023
Study Start
September 30, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2025
Last Updated
November 7, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share