ClinicalTrials.gov
ClinicalTrials.gov Menu

Biomarkers in Acute Cardiac Care (BACC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02355457
Recruitment Status : Recruiting
First Posted : February 4, 2015
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
PD Dr. Dirk Westermann, 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.

Condition or disease
Acute Coronary Syndrome Myocardial Infarction Chest Pain

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 [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Biomarkers in Acute Cardiac Care
Study Start Date : July 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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



Primary Outcome Measures :
  1. Acute myocardial infarction as index event [ Time Frame: Months ]
    The primary endpoint of the study is acute myocardial infarction


Secondary Outcome Measures :
  1. AMI, Mortality, heart failure and quality of life [ Time Frame: Years ]
    The secondary endpoint of the study is mortality, heart failure, quality of life.


Biospecimen Retention:   Samples With DNA
blood samples, white blood cells.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355457


Contacts
Contact: Johannes T Neumann, MD 0049407410 ext 56800 j.neumann@uke.de
Contact: Dirk Westermann, MD 0049407410 ext 56800 d.westermann@uke.de

Locations
Germany
Department of General and Interventional Cardiology, University Heart Center Hamburg Recruiting
Hamburg, Germany, 20246
Contact: Mahir Karakas, MD    0049407410 ext 57975    m.karakas@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Dirk Westermann, MD UHZ
Principal Investigator: Stefan Blankenberg, MD UHZ

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. Dirk Westermann, Senior Physician at the Department for General and Interventional Cardiology, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02355457     History of Changes
Other Study ID Numbers: PV4306
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by PD Dr. Dirk Westermann, Universitätsklinikum Hamburg-Eppendorf:
troponin
myocardial infarction
acs
AMI
biomarker
BACC
high-sensitivity

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Chest Pain
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms