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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06175572
Other study ID # ZS20231202
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2022

Study information

Verified date December 2023
Source Shanghai Zhongshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To validate and investigate the efficacy of comprehensive functional assessments for the diagnostic and prognostic value in NOCAD.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date December 31, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. visual evaluation of epicardial coronary artery diameter stenosis (DS%) = 50%; 2. CZT-SPECT was successfully conducted within three days of CAG Exclusion Criteria: 1. had flow-limiting epicardial stenosis (DS% >50%) or angiography-derived FFR (Angio-FFR) = 0.8; 2. severe valvular heart disease; 3. chronic heart failure and/or left ventricular ejection fraction (LVEF) of < 50%; 4. cardiomyopathy and myocarditis; 5. severe renal or hepatic insufficiency; 6. failure in detecting SPECT; 7. failure in computing Angio-IMR, and -FFR.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
coronary physiological indices
coronary physiological indices

Locations

Country Name City State
China Zhongshan hospital, Fudan university Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major adverse cardiac events (MACE) The composite of coronary heart disease death, nonfatal myocardial infarction, hospitalization for unstable angina, or fatal or nonfatal ischemic stroke. 5 years
Secondary Individual components of MACE Cumulative incidence of the individual components of MACE 5 years
Secondary the change in Seattle Angina Questionnaire (SAQ) summary score The SAQ comprises 5 components namely physical limitation, angina stability, angina frequency, treatment satisfaction, and quality of life; these are then incorporated into the summary score. The higher the score, the better the patient's quality of life and physical function. 5 years
Secondary the change in Seattle Angina Questionnaire (SAQ) score of indivadual scale The SAQ comprises 5 components namely physical limitation, angina stability, angina frequency, treatment satisfaction, and quality of life. The higher the score, the better the patient's quality of life or physical function. 5 years
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