Myocardial Infarction Registry

Acute Coronary Syndrome Clinical Trial

— MIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128317
• Other study ID #: MIR
• Status: Recruiting
• Start date: August 1, 2014
• Est. completion date: December 31, 2030

Study information

• Verified date: November 2023
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2030
• Est. primary completion date: January 1, 2030
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Other:
• no intervention is intended.
no intervention is intended.

Locations

Country	Name	City	State
Germany	University Hospital of Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality	all-cause mortality during follow-up	12 months
Secondary	myocardial infarction	myocardial infarction during follow-up	12 months
Secondary	stroke	stroke during follow-up	12 months
Secondary	Rehospitalization	Rehospitalization during follow-up	12 months