Clinical trial NCT06119022: CT Myocardial Perfusion to Guide the Diagnosis and Treatment of Patients With Stable Coronary Artery Disease (POTENTIAL)
Official title: CT Myocardial Perfusion Imaging to Guide the Diagnosis and Treatment of Patients With Stable Coronary Artery Disease: a Randomized Controlled Study (POTENTIAL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Treatment Decision, Coronary Artery Disease
Keywords: CT myocardial perfusion imaging
Coronary artery disease
clinical pathway
SPECT myocardial perfusion imaging
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of non-revascularization treatment of the two arms
timeFrame: within 90 days after CT-MPI or SPECT-MPI examination
Secondary outcomes:
measure: The rate of major adverse cardiovascular events of the two arms
timeFrame: One year after CT-MPI or SPECT-MPI
measure: Difference in quality of Life of the two arms
timeFrame: One year after CT-MPI or SPECT-MPI
measure: Difference in cost of the two arms
timeFrame: One year after CT-MPI or SPECT-MPI
measure: Difference in cumulative radiation exposure dose of the two arms
timeFrame: Total cumulative radiation exposure dose during CT-MPI or SPECT-MPI and invasive coronary angiography within one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
state: Beijing
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hosptial of Zhengzhou University
state: Henan
city: Changchun
country: China
facility: The Second Norman Bethune Hospital of Jilin University
state: Jilin
Study officials:
References: