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COMBAT-CAD: Combined Use of Multiple Biomarkers With Stress Testing to Detect Coronary Artery Disease

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Completed
CT.gov ID
NCT03137550
Collaborator
(none)
850
Enrollment
1
Location
60.6
Actual Duration (Months)
14
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Main aim of the COMBAT-CAD-Study is to clarify, if the combination of stress testing with biomarkers improves the diagnostic accuracy.

Hypothesis of our study is that diagnosis of CAD can be improved by adding biomarkers to solely stress testing for the workup of patients with suspected CAD or progress of already known CAD.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The COMBAT-CAD Study is an observational study with the aim to improve the diagnostic accuracy by a combination of stress testing with sensitive and specific biomarkers in detecting coronary artery disease or its progress. The main subjects are all patients with CAD or suspicion of CAD sent to the University Heart Center Hamburg. In these patients, ECG, laboratory examination, symptoms or transthoracic echocardiography in rest could not rule out CAD or progress of known CAD. The hypothesis of the study is that detection of CAD can be improved by adding biomarkers to stress testing for the diagnostic workup of patients with suspected CAD or progress of already known CAD.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    850 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Combined Use of Multiple Biomarkers With Stress Testing to Detect Coronary Artery Disease
    Actual Study Start Date :
    Apr 12, 2017
    Actual Primary Completion Date :
    Dec 31, 2021
    Actual Study Completion Date :
    Apr 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Diagnosis of coronary artery disease [Within the initial diagnostic evaluation process (maximum within 30 days)]

      The diagnosis of coronary artery disease through stress testing alone and combined with cardiac biomarkers.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Every patient referred to coronary angiography, or diagnostic work-up with suspicion of CAD or progress of CAD (in case of CABG patients or already treated with PCI)
    Exclusion Criteria:

    1. Insufficient knowledge of the German language (able to understand and write the German language)

    2. Physical or psychological incapability to take part in the investigation

    3. Persons with no sufficient language ability in German to understand the provided study information material.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of General and Interventional Cardiology, University Heart Center Hamburg Hamburg Germany 20246

    Sponsors and Collaborators

    • Universitätsklinikum Hamburg-Eppendorf

    Investigators

    • Principal Investigator: Stefan Blankenberg, MD, Head of the Department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitätsklinikum Hamburg-Eppendorf
    ClinicalTrials.gov Identifier:
    NCT03137550
    Other Study ID Numbers:
    • PV4023
    First Posted:
    May 2, 2017
    Last Update Posted:
    May 31, 2022
    Last Verified:
    May 1, 2022
    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
    Myocardial Ischemia
    Coronary Disease

    Study Results

    No Results Posted as of May 31, 2022