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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

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 Type: Observational
• Enrollment (Actual): 850

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Department of General and Interventional Cardiology, University Heart Center Hamburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Eligible are all patients who receive stress testing ordered by a physician of the University Heart Center and who are willing and able to participate in an observational study. Participants of interest are outpatients and inpatients of the University Heart Centre.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Stefan Blankenberg, MD, Head of the department

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2017
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: PV4023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No