Comprehensive Functional Assessments for NOCAD

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

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

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Coronary Microvascular Dysfunction
• Intervention / Treatment: Device: coronary physiological indices

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population enrolled from Zhongshan Hospital, Fudan University (Shanghai, China)，with coronary angiography and available cadmium zinc telluride - single photon emission computed tomography imaging (CZT-SPECT).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NCF cohort; Normanl coronary-flow patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT).	Device: coronary physiological indices; coronary physiological indices
CSF cohort; Coronary slow-flow patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT).	Device: coronary physiological indices; coronary physiological indices
ANOCA cohort; Angina with nonobstructive coronary artery patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT).	Device: coronary physiological indices; coronary physiological indices
INOCA cohort; Ischemia with nonobstructive coronary artery patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT).	Device: coronary physiological indices; coronary physiological indices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual components of MACE	Cumulative incidence of the individual components of MACE	5 years
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
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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Director: Chenguang Li, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Estimated): December 19, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia
• Other Study ID Numbers: ZS20231202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No