Comprehensive Assessment on Diagnostic and Prognostic Performance of Coronary Physiological Indices

Active, not recruiting

• Conditions: Coronary Artery Disease
• Interventions: Other: coronary physiological indices

• Registration Number: NCT06127420
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

The objective of the Zhongshan Hospital CONCORDE Registry is to evaluate utility, diagnostic value, and clinical outcomes of coronary physiological indices in an all-comers population of patients with suspected coronary artery disease referred to invasive coronary angiography in order to further inform patients and health care providers about which technologies are most effective and efficient in the diagnosis and management of coronary artery diseases.

Detailed Description

CONCORDE registry offers a comprehensive pressure and/or flow measurements, as well as angiography-derived functional assessment of coronary. Patient treatment was at the operator's discretion at the time of the invasive procedure. A standardized data collection sheet was used and data were extracted from electrical medical history according to standardized definition of patient's baseline characteristics, clinical outcomes, and physiologic data.

Study Timeline

• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-13
• Study Start: 2023-12-06
• Status Verified: 2024-05
• Primary Completion: 2024-05-07
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• suspected coronary artery disease
• referred to invasive coronary angiography

Exclusion Criteria

• hemodynamic instability

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	coronary physiological indices	All patients referred to angiography and undergo assessment with coronary pressure sensor

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events (MACE)	5 years	Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization

Secondary Outcome Measures

Name	Time	Method
Target vessel failure (TVF)	5 years	Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization
Individual components of MACE and TVF	5 years	Cumulative incidence of the individual components of MACE and TVF

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China