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NCT06127420 Clinical Trial

Comprehensive Assessment on Diagnostic and Prognostic Performance of Coronary Physiological Indices

Coronary Artery Disease Clinical Trial

— CONCORDE  

Official title:
Comprehensive Assessment on Diagnostic and Prognostic Performance of Coronary Physiological Indices in Patients Referred to Angiography

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06127420
Other study ID # ZSCD2023001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 6, 2023
Est. completion date November 2024

Study information
Verified date May 2024
Source Shanghai Zhongshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 3000
Est. completion date November 2024
Est. primary completion date May 7, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - suspected coronary artery disease - referred to invasive coronary angiography Exclusion Criteria: - hemodynamic instability

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• coronary physiological indices
Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Resting full-cycle ratio, Coronary Flow Reserve, Microvascular resistance

Locations
Country Name City State
China Zhongshan Hospital Shanghai 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) Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization 5 years
Secondary Target vessel failure (TVF) Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization 5 years
Secondary Individual components of MACE and TVF Cumulative incidence of the individual components of MACE and TVF 5 years
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