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Clinical Trials/NCT06128317
NCT06128317
Recruiting
Not Applicable

Cardiac Biochemical and Omics-based Biomarkers in Patients Presenting Symptoms of Acute Coronary Syndrome in the Emergency Department (ACS Registry)

University Hospital Heidelberg1 site in 1 country2,500 target enrollmentAugust 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
University Hospital Heidelberg
Enrollment
2500
Locations
1
Primary Endpoint
all-cause mortality
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The single-center MIR-registry was created to assess real-world prevalence, demographic characteristics and management of patients with acute coronary syndrome presenting in the emergency department (ED) of University of Heidelberg.

Detailed Description

To conduct a comprehensive characterization of patients with symptoms of acute coronary syndrome or elevated troponin levels. Records include clinical routine parameters, there will be an expansion involving the collection of blood samples for the analysis of novel laboratory-based and omics-based biomarkers. The ACS registry is monothetically managed by the Department of Internal Medicine III at Heidelberg University Hospital and is intended to serve as a basis for further clinical diagnostic and outcome studies. The blood samples will serve as the foundation for a comprehensive analysis of established and novel laboratory-based markers, as well as omics-based biomarkers (miRNA, metabolomics, and proteomics). Follow-up was performed via review of medical reports, phone calls and postal queries. The outcome parameters comprised rates for all-cause mortality, non-hemorrhagic stroke, myocardial infarction, and hospitalization for any cause.

Registry
clinicaltrials.gov
Start Date
August 1, 2014
End Date
December 31, 2030
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mustafa Yildirim

Dr. med. univ.

University Hospital Heidelberg

Eligibility Criteria

Inclusion Criteria

  • The study will include consecutive patients who present to the cardiology emergency department at Heidelberg University Hospital with symptoms of acute coronary syndrome or a troponin increase (hs-TnT \>14 ng/L). Additional inclusion criteria are a minimum age of 18 years and providing informed consent through written consent to participate in the study. The following medical conditions are intended to be distinguished from one another:
  • Acute myocardial infarction
  • Unstable angina pectoris
  • Myocarditis
  • Heart failure
  • Cardiomyopathies
  • Pulmonary embolism
  • Renal insufficiency
  • Supraventricular and ventricular tachycardias
  • Hypertensive crisis

Exclusion Criteria

  • Exclusion criteria are defined according to GCP (Good Clinical Practice), i.e., mental illnesses/dementia (lack of capacity to provide informed consent), pregnancy/breastfeeding, as well as acute conditions requiring immediate treatment (e.g., cardiogenic shock).

Outcomes

Primary Outcomes

all-cause mortality

Time Frame: 12 months

all-cause mortality during follow-up

Secondary Outcomes

  • stroke(12 months)
  • Rehospitalization(12 months)
  • myocardial infarction(12 months)

Study Sites (1)

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