Biomarkers in Acute Cardiac Care (BACC)

December 4, 2023 updated by: Universitätsklinikum Hamburg-Eppendorf
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Johannes T Neumann, MD
  • Phone Number: 56800 0049407410
  • Email: j.neumann@uke.de

Study Contact Backup

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • Department of Cardiology, University Heart Center Hamburg
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients presenting with suspected myocardial infarction in the emergency department or the chest pain unit of the University Hospital Hamburg-Eppendorf.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Suspected acute myocardial infarction
Patients with recent onset symptoms suggesting acute myocardial infarction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute myocardial infarction as index event
Time Frame: Months
The primary endpoint of the study is acute myocardial infarction
Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMI, Mortality, heart failure and quality of life
Time Frame: Years
The secondary endpoint of the study is mortality, heart failure, quality of life.
Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Johannes Neumann, MD, UHZ
  • Principal Investigator: Nils Sörensen, MD, UHZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 30, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (Estimated)

February 4, 2015

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV4306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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