Biomarkers in Acute Cardiac Care

Myocardial Infarction Clinical Trial

— BACC  

Official title:

Biomarkers in Acute Cardiac Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02355457
• Other study ID #: PV4306
• Status: Recruiting
• Start date: July 2013
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Johannes T Neumann, MD
• Phone: 0049407410
• Email: j.neumann[@]uke.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain
• Infarction
• Myocardial Infarction

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Neumann JT, Sorensen NA, Ojeda F, Schwemer T, Lehmacher J, Gonner S, Jarsetz N, Keller T, Schaefer S, Renne T, Landmesser U, Clemmensen P, Makarova N, Schnabel RB, Zeller T, Karakas M, Pickering JW, Than M, Parsonage W, Greenslade J, Cullen L, Westermann — View Citation

Neumann JT, Sorensen NA, Schwemer T, Ojeda F, Bourry R, Sciacca V, Schaefer S, Waldeyer C, Sinning C, Renne T, Than M, Parsonage W, Wildi K, Makarova N, Schnabel RB, Landmesser U, Mueller C, Cullen L, Greenslade J, Zeller T, Blankenberg S, Karakas M, West — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute myocardial infarction as index event	The primary endpoint of the study is acute myocardial infarction	Months
Secondary	AMI, Mortality, heart failure and quality of life	The secondary endpoint of the study is mortality, heart failure, quality of life.	Years