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CONCORDE: Comprehesive Assessment on diagnOstic and progNostic Performance of CORonary Physilogical inDices

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06127420
Collaborator
(none)
3,000
Enrollment
11
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The objective of the Zhongshan Hospital CONCORDE Registry is to evaluate utility, diagnostic value, and clinical outcomes of coronary physilogical 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 providersabout which technologies are most effective and efficient in the diagnosis and management of CAD.

Condition or Disease Intervention/Treatment Phase
  • Other: coronary physiological indices

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Comprehesive Assessment on diagnOstic and progNostic Performance of CORonary Physilogical inDices in patiEnts Referred to Angiography
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm 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, Reseting full-cycle ratio, Coronary Flow Reserve, Microvascular resistance

Outcome Measures

Primary Outcome Measures

  1. Major adverse cardiac events [5 years]

    Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization

Secondary Outcome Measures

  1. Target vessel failure [5 years]

    Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization

  2. Individual components of MACE and TVF [5 years]

    Cumulative incidence of the individual components of MACE and TVF

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • suspected coronary artery disease

  • referred to invasive coronary angiography

Exclusion Criteria:
  • hemodynamic instability

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Zhongshan Hospital

Investigators

  • Study Director: Chenguang Li, Shanghai Zhongshan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Junbo Ge, Professor, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT06127420
Other Study ID Numbers:
  • ZSCD2023001
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Coronary Artery Disease

Study Results

No Results Posted as of Nov 13, 2023