NCT06127420

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

December 6, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

November 7, 2023

Last Update Submit

May 8, 2024

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events (MACE)

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

    5 years

Secondary Outcomes (2)

  • Target vessel failure (TVF)

    5 years

  • Individual components of MACE and TVF

    5 years

Study Arms (1)

All patients

All patients referred to angiography and undergo assessment with coronary pressure sensor

Other: coronary physiological indices

Interventions

coronary physiological indicesOTHER

Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Resting full-cycle ratio, Coronary Flow Reserve, Microvascular resistance

All patients

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • suspected coronary artery disease
  • referred to invasive coronary angiography

You may not qualify if:

  • hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Chenguang Li

    Shanghai Zhongshan Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 13, 2023

Study Start

December 6, 2023

Primary Completion

May 7, 2024

Study Completion

November 1, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)