Comprehensive Functional Assessments for NOCAD

Coronary Artery Disease Clinical Trial

Official title:

The Diagnostic and Prognostic Value of Comprehensive Functional Assessments for Non-obstructive Coronary Artery Diseases.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06175572
• Other study ID #: ZS20231202
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Microvascular Dysfunction
• Ischemia
• Myocardial Ischemia

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