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

Coronary Artery Disease Clinical Trial

— COMBAT-CAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137550
• Other study ID #: PV4023
• Status: Completed
• Start date: April 12, 2017
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: April 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Germany	Department of General and Interventional Cardiology, University Heart Center Hamburg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of coronary artery disease	The diagnosis of coronary artery disease through stress testing alone and combined with cardiac biomarkers.	Within the initial diagnostic evaluation process (maximum within 30 days)