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

Recruiting
18 - 80 years of age
Both
Phase N/A

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Overview

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).

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

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 details

Treatment Decision, Coronary Artery Disease

NCT06119022

Chinese Academy of Medical Sciences, Fuwai Hospital

25 January 2024

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