Clinical trial NCT06128317: Myocardial Infarction Registry
Official title: Cardiac Biochemical and Omics-based Biomarkers in Patients Presenting Symptoms of Acute Coronary Syndrome in the Emergency Department (ACS Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A cohort consisting of consecutive patients with suspected acute coronary syndrome presenting to the emergency department of the Heidelberg University Hospital.

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.

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
* Non-cardiac chest pain

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).

Primary outcomes:
measure: all-cause mortality
timeFrame: 12 months
Secondary outcomes:
measure: myocardial infarction
timeFrame: 12 months
measure: stroke
timeFrame: 12 months
measure: Rehospitalization
timeFrame: 12 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital of Heidelberg
state: Baden-Württemberg
Study officials:
References: