Comprehensive Functional Assessments for NOCAD

NCT06175572 | Completed

• 1 other identifier: ZS20231202
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease; Myocardial Ischemia; Coronary Microvascular Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (4)

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

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

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

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

Interventions

coronary physiological indices DEVICE

coronary physiological indices

ANOCA cohort; CSF cohort; INOCA cohort; NCF cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• visual evaluation of epicardial coronary artery diameter stenosis (DS%) ≤ 50%;
• CZT-SPECT was successfully conducted within three days of CAG

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan hospital, Fudan university

Shanghai, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Chenguang Li

  Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 19, 2023
• Study Start: January 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)