Myocardial Infarction Registry (MIR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Other: no intervention is intended.

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 Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Recruiting
      • University Hospital of Heidelberg
      • Contact: Mustafa Yildirim, MD; Phone Number: +496221/56-310918; Email: Mustafa.yildirim@med.uni-heidelberg.de
      • Contact: Evangelos Giannitsis, Prof. MD; Email: Evangelos.Giannitsis@med.uni-heidelberg.de
      • Principal Investigator: Matthias Mueller-Hennessen, Prof. MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MIR (Myocardial Infarction Registry); All patients presenting to the Emergency Department with suspected acute coronary syndrome	Other: no intervention is intended.; no intervention is intended.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality	all-cause mortality during follow-up	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
myocardial infarction	myocardial infarction during follow-up	12 months
stroke	stroke during follow-up	12 months
Rehospitalization	Rehospitalization during follow-up	12 months

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: MIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No