NCT06175572CompletedNot Applicable
The Diagnostic and Prognostic Value of Comprehensive Functional Assessments for Non-obstructive Coronary Artery Diseases.
Shanghai Zhongshan Hospital1 site in 1 country1,000 target enrollmentStarted: January 1, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Major adverse cardiac events (MACE)
Study Overview
Brief Summary
To validate and investigate the efficacy of comprehensive functional assessments for the diagnostic and prognostic value in NOCAD.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •visual evaluation of epicardial coronary artery diameter stenosis (DS%) ≤ 50%;
- •CZT-SPECT was successfully conducted within three days of CAG
Exclusion Criteria
- •had flow-limiting epicardial stenosis (DS% >50%) or angiography-derived FFR (Angio-FFR) ≤ 0.8;
- •severe valvular heart disease;
- •chronic heart failure and/or left ventricular ejection fraction (LVEF) of < 50%;
- •cardiomyopathy and myocarditis;
- •severe renal or hepatic insufficiency;
- •failure in detecting SPECT;
- •failure in computing Angio-IMR, and -FFR.
Outcomes
Primary Outcomes
Major adverse cardiac events (MACE)
Time Frame: 5 years
The composite of coronary heart disease death, nonfatal myocardial infarction, hospitalization for unstable angina, or fatal or nonfatal ischemic stroke.
Secondary Outcomes
- Individual components of MACE(5 years)
- the change in Seattle Angina Questionnaire (SAQ) summary score(5 years)
- the change in Seattle Angina Questionnaire (SAQ) score of indivadual scale(5 years)
Investigators
Junbo Ge
Professor
Shanghai Zhongshan Hospital
Study Sites (1)
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