Treatment Decision, Coronary Artery Disease
Conditions
Keywords
CT myocardial perfusion imaging, Coronary artery disease, clinical pathway, SPECT myocardial perfusion imaging
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.
Interventions
PROCEDUREInvasive 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.
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.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of non-revascularization treatment of the two arms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of major adverse cardiovascular events of the two arms | 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. |
| Difference in quality of Life of the two arms | One year after CT-MPI or SPECT-MPI | The Seattle Angina Questionnaire |
| Difference in cost of the two arms | One year after CT-MPI or SPECT-MPI | Total clinical cost |
| 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 | Total cumulative radiation exposure dose |
Countries
China
Contacts
Primary ContactYang Gao, M.D
Outcome results
None listed