Biomarkers in Acute Cardiac Care

Recruiting

• Conditions: Chest Pain; Acute Coronary Syndrome; Myocardial Infarction

• Registration Number: NCT02355457
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

The primary aim of the study is to investigate new cardiac biomarkers and algorithms to diagnose acute coronary syndrome in patients with suspected acute myocardial infarction.

Detailed Description

The primary aim of the study is to detect and evaluate new cardiac biomarkers, evaluate and improve acute coronary syndrome (ACS) risk scores, which takes into account clinical, gender specific, psycho-social and lifestyle-risk factors, protein patterns and genetic variability in addition to the classical risk factors with respect to the primary endpoint of acute myocardial infarction.

Secondary study aims are :

* To provide estimates for the incidence of ACS in patients presenting with recent onset chest pain;

* To provide accurate, quantifiable measures of precursors of ACS;

* DNA, RNA, cells, and serum/plasma for comprehensive genetic, gene expression and proteomic studies

* To explore the impact of ACS candidate genes on cardiovascular risk stratification by using genome-wide analyses and a biological systems approach;

* To explore proteins relevant for ACS;

* To allow the identification of new therapeutic targets;

* To evaluate the impact of socio-economic factors on ACS and CAD risk.

Patients will be followed up during the hospital stay. Afterwards a telephone follow-up will take place after 30 days, 6, 24 and 48 months.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2015-01-30
• Study First Submitted QC: 2015-01-30
• Study First Posted: 2015-02-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Symptoms suggestive of acute myocardial infarction
• Ability to provide written informed consent in accordance with Good epidemiological Practice and local legislation
• Individuals at least 18 years old

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute myocardial infarction as index event	Months	The primary endpoint of the study is acute myocardial infarction

Secondary Outcome Measures

Name	Time	Method
AMI, Mortality, heart failure and quality of life	Years	The secondary endpoint of the study is mortality, heart failure, quality of life.

Trial Locations

Locations (1)

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