Comprehensive Assessment on Diagnostic and Prognostic Performance of Coronary Physiological Indices (CONCORDE)

December 11, 2023 updated by: Junbo Ge, Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A all-comer population of patients with suspected coronary artery disease referred to invasive angiography at Zhongshan Hospital.

Description

Inclusion Criteria:

  • suspected coronary artery disease
  • referred to invasive coronary angiography

Exclusion Criteria:

  • hemodynamic instability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients
All patients referred to angiography and undergo assessment with coronary pressure sensor
Other: coronary physiological indices
Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Resting full-cycle ratio, Coronary Flow Reserve, Microvascular resistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events (MACE)
Time Frame: 5 years
Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Study Director: Chenguang Li, Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSCD2023001

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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