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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
660
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.
Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGFuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
ACTIVE_NOT_RECRUITINGThe First Affiliated Hosptial of Zhengzhou University
Zhengzhou, Henan, China
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.
Time frame: within 90 days after CT-MPI or SPECT-MPI examination
The rate of major adverse cardiovascular events of the two arms
The composition of all-cause death, non-fatal myocardial infarction, stroke, revascularization, and hospital admissions for unstable angina.
Time frame: One year after CT-MPI or SPECT-MPI
Difference in quality of Life of the two arms
The Seattle Angina Questionnaire
Time frame: One year after CT-MPI or SPECT-MPI
Difference in cost of the two arms
Total clinical cost
Time frame: One year after CT-MPI or SPECT-MPI
Difference in cumulative radiation exposure dose of the two arms
Total cumulative radiation exposure dose
Time frame: Total cumulative radiation exposure dose during CT-MPI or SPECT-MPI and invasive coronary angiography within one year
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The Second Norman Bethune Hospital of Jilin University
Changchun, Jilin, China
ACTIVE_NOT_RECRUITING