Acute Coronary SyndromeMIRNCT06128317
Myocardial Infarction Registry
An observational study of Acute Coronary Syndrome, run by University Hospital Heidelberg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 2,500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2014to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: A cohort consisting of consecutive patients with suspected acute coronary syndrome presenting to the emergency department of the Heidelberg University Hospital.
Who may be able to join
- 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
Show all 11Show fewer
- Pulmonary embolism
- Renal insufficiency
- Supraventricular and ventricular tachycardias
- Hypertensive crisis
- Non-cardiac chest pain
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Mustafa Yildirim, MD, +496221/56-310918, Mustafa.yildirim@med.uni-heidelberg.de
Evangelos Giannitsis, Prof. MD, Evangelos.Giannitsis@med.uni-heidelberg.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- no intervention is intended.
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention is intended.Other
no intervention is intended.
| Study group | Role | What they receive |
|---|---|---|
| MIR (Myocardial Infarction Registry) | All patients presenting to the Emergency Department with suspected acute coronary syndrome Receives: Other: no intervention is intended. |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
all-cause mortality during follow-up
Measured: 12 months
Secondary outcomes (3)
myocardial infarction
myocardial infarction during follow-up
Measured: 12 months
stroke
stroke during follow-up
Measured: 12 months
Rehospitalization
Rehospitalization during follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Aug 2014
- Primary completion1 Jan 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Yildirim, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128317
- Sponsor's protocol ID
- MIR
- Acronym
- MIR
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yildirim M, Salbach C, Mueller-Hennessen M, Frey N, Giannitsis E. Comparative Analysis of Single- and Dual-Marker Strategies for Rapid Non-ST-Segment-Elevation Myocardial Infarction Rule-Out Using Cardiac Myosin-Binding Protein C, Copeptin, and High-Sensitivity Cardiac Troponin T in the Emergency Department. J Am Heart Assoc. 2025 May 20;14(10):e039379. doi: 10.1161/JAHA.124.039379. Epub 2025 May 13.
PubMed 40357668Yildirim M, Salbach C, Reich C, Milles BR, Biener M, Frey N, Giannitsis E, Mueller-Hennessen M. Comparison of the clinical chemistry score to other biomarker algorithms for rapid rule-out of acute myocardial infarction and risk stratification in patients with suspected acute coronary syndrome. Int J Cardiol. 2024 Apr 1;400:131815. doi: 10.1016/j.ijcard.2024.131815. Epub 2024 Jan 24.
PubMed 38278492
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Biochemical and Omics-based Biomarkers in Patients Presenting Symptoms of Acute Coronary Syndrome in the Emergency Department (ACS Registry)
- ClinicalTrials.gov ID
- NCT06128317
- Acronym / sponsor ID
- MIR / MIR
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIR (Myocardial Infarction Registry) | – | Other: no intervention is intended.All patients presenting to the Emergency Department with suspected acute coronary syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A cohort consisting of consecutive patients with suspected acute coronary syndrome presenting to the emergency department of the Heidelberg University Hospital.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention is intended.no intervention is intended. | Other | MIR (Myocardial Infarction Registry) |
Primary outcome
all-cause mortality
Time frame: 12 months
all-cause mortality during follow-up
3 secondary outcomes
myocardial infarction
Time frame: 12 months
stroke
Time frame: 12 months
Rehospitalization
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 40357668Yildirim M, Salbach C, Mueller-Hennessen M, Frey N, Giannitsis E. Comparative Analysis of Single- and Dual-Marker Strategies for Rapid Non-ST-Segment-Elevation Myocardial Infarction Rule-Out Using Cardiac Myosin-Binding Protein C, Copeptin, and High-Sensitivity Cardiac Troponin T in the Emergency Department. J Am Heart Assoc. 2025 May 20;14(10):e039379. doi: 10.1161/JAHA.124.039379. Epub 2025 May 13.
- Derived from this study: PubMed 38278492Yildirim M, Salbach C, Reich C, Milles BR, Biener M, Frey N, Giannitsis E, Mueller-Hennessen M. Comparison of the clinical chemistry score to other biomarker algorithms for rapid rule-out of acute myocardial infarction and risk stratification in patients with suspected acute coronary syndrome. Int J Cardiol. 2024 Apr 1;400:131815. doi: 10.1016/j.ijcard.2024.131815. Epub 2024 Jan 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University Hospital of Heidelberg
Heidelberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06128317, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.