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

NCT03137550 | Completed

• 1 other identifier: PV4023
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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)

You may not qualify if:

• Insufficient knowledge of the German language (able to understand and write the German language)
• Physical or psychological incapability to take part in the investigation
• Persons with no sufficient language ability in German to understand the provided study information material.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department of General and Interventional Cardiology, University Heart Center Hamburg

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Stefan Blankenberg, MD

  Head of the Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 2, 2017
• Study Start: April 12, 2017
• Primary Completion: December 31, 2021
• Study Completion: April 30, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)