Biomarkers in Acute Cardiac Care

NCT ID: NCT02355457

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2027-12-31

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.

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Chest Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Suspected acute myocardial infarction

Patients with recent onset symptoms suggesting acute myocardial infarction

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johannes Neumann, MD

Role: PRINCIPAL_INVESTIGATOR

UHZ

Nils Sörensen, MD

Role: PRINCIPAL_INVESTIGATOR

UHZ

Locations

Department of Cardiology, University Heart Center Hamburg

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Johannes T Neumann, MD

Role: CONTACT

j.neumann@uke.de

0049407410 ext. 56800

Nils Sörensen, MD

Role: CONTACT

n.soerensen@uke.de

0049407410 ext. 56800

Facility Contacts

Johannes Neumann, MD

Role: primary

j.neumann@uke.de

0049407410 ext. 56800

References

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Sorensen NA, Neumann JT, Ojeda F, Schwemer T, Renne T, Schnabel RB, Zeller T, Karakas M, Blankenberg S, Westermann D. Challenging the 99th percentile: A lower troponin cutoff leads to low mortality of chest pain patients. Int J Cardiol. 2017 Apr 1;232:289-293. doi: 10.1016/j.ijcard.2016.12.167. Epub 2016 Dec 27.

Reference Type: DERIVED

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Other Identifiers

PV4306

Identifier Type: -

Identifier Source: org_study_id