MIR: Myocardial Infarction Registry

Sponsor
University Hospital Heidelberg (Other)
Overall Status
Recruiting
CT.gov ID
NCT06128317
Collaborator
(none)
2,500
1
197
12.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
2500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cardiac Biochemical and Omics-based Biomarkers in Patients Presenting Symptoms of Acute Coronary Syndrome in the Emergency Department (ACS Registry)
Actual Study Start Date :
Aug 1, 2014
Anticipated Primary Completion Date :
Jan 1, 2030
Anticipated Study Completion Date :
Dec 31, 2030

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. all-cause mortality [12 months]

    all-cause mortality during follow-up

Secondary Outcome Measures

  1. myocardial infarction [12 months]

    myocardial infarction during follow-up

  2. stroke [12 months]

    stroke during follow-up

  3. Rehospitalization [12 months]

    Rehospitalization during follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Heidelberg Heidelberg Baden-Württemberg Germany 69120

Sponsors and Collaborators

  • University Hospital Heidelberg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mustafa Yildirim, Dr. med. univ., University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT06128317
Other Study ID Numbers:
  • MIR
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 14, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2023