Myocardial Infarction Registry

Recruiting

• Conditions: Acute Coronary Syndrome
• Interventions: Other: no intervention is intended.

• Registration Number: NCT06128317
• Lead Sponsor: University Hospital Heidelberg

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.

Study Timeline

• Study Start: 2014-08-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-13
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14
• Primary Completion: 2030-01-01
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MIR (Myocardial Infarction Registry)	no intervention is intended.	All patients presenting to the Emergency Department with suspected acute coronary syndrome

Primary Outcome Measures

Name	Time	Method
all-cause mortality	12 months	all-cause mortality during follow-up

Secondary Outcome Measures

Name	Time	Method
stroke	12 months	stroke during follow-up
Rehospitalization	12 months	Rehospitalization during follow-up
myocardial infarction	12 months	myocardial infarction during follow-up

Trial Locations

Locations (1)

University Hospital of Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany