Combined Use of Multiple Biomarkers With Stress Testing to Detect Coronary Artery Disease

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT03137550
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

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 Timeline

• Study Start: 2017-04-12
• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-04-28
• Study First Posted: 2017-05-02
• Primary Completion: 2021-12-31
• Study Completion: 2022-04-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-27
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 850

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of General and Interventional Cardiology, University Heart Center Hamburg; 🇩🇪 Hamburg, Germany