Antiplatelets and Intramyocardial Hemorrhage in STEMI: Incidence and Outcomes

NCT ID: NCT06851325

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-02-11

Brief Summary

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The MIRON-PLATELET study is a retrospective, observational multi-center analysis assessing the impact of different antiplatelet therapies on hemorrhagic myocardial infarction (HMI) incidence and outcomes in STEMI patients. Key endpoints include hemorrhagic transformation, MACE, bleeding complications, and 30-day mortality. Findings will offer insights into the safety and clinical implications of antiplatelet therapy in high-risk patients.

Detailed Description

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Conditions

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STEMI Acute Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18-79 years at the time of STEMI diagnosis
2. Diagnosed with ST-segment elevation myocardial infarction (STEMI) based on standard clinical criteria
3. Received antiplatelet therapy as part of STEMI management
4. Underwent primary percutaneous coronary intervention (PCI)
5. Evidence of hemorrhagic MI confirmed by Cardiac Magnetic Resonance Imaging OR Post-PCI biomarker diagnostics
6. Availability of comprehensive medical records documenting STEMI presentation, treatment details, and clinical outcomes
7. Minimum of 30-day follow-up data, with extended follow-up available for up to 10 years

Exclusion Criteria

1. Diagnosis of non-STEMI (NSTEMI), unstable angina, or other non-ischemic cardiomyopathies
2. History of prior hemorrhagic stroke or active intracranial bleeding before the index STEMI event
3. Known bleeding disorders (e.g., hemophilia, thrombocytopenia \<50,000/µL)
4. Use of chronic antiplatelet therapy (aspirin, clopidogrel, ticagrelor, prasugrel) before STEMI diagnosis
5. Use of long-term anticoagulation therapy (warfarin, DOACs such as apixaban, rivaroxaban, dabigatran) before STEMI diagnosis
6. Incomplete or missing medical records preventing outcome assessment
7. History of malignancy with life expectancy \<1 year at the time of STEMI diagnosis
8. Patients lost to follow-up before 30 days post-STEMI
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rohan Dharmakumar

OTHER

Sponsor Role lead

Responsible Party

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Rohan Dharmakumar

Executive Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rohan Dharmakumar, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Keyur P. Vora, MD FACC

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Krannert Cardiovascular Research Center

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Vyas R, Changal KH, Bhuta S, Pasadyn V, Katterle K, Niedoba MJ, Vora K, Dharmakumar R, Gupta R. Impact of Intramyocardial Hemorrhage on Clinical Outcomes in ST-Elevation Myocardial Infarction: A Systematic Review and Meta-analysis. J Soc Cardiovasc Angiogr Interv. 2022 Aug 26;1(6):100444. doi: 10.1016/j.jscai.2022.100444. eCollection 2022 Nov-Dec.

Reference Type BACKGROUND
PMID: 39132339 (View on PubMed)

Vora KP, Kumar A, Krishnam MS, Prato FS, Raman SV, Dharmakumar R. Microvascular Obstruction and Intramyocardial Hemorrhage in Reperfused Myocardial Infarctions: Pathophysiology and Clinical Insights From Imaging. JACC Cardiovasc Imaging. 2024 Jul;17(7):795-810. doi: 10.1016/j.jcmg.2024.02.003. Epub 2024 Apr 10.

Reference Type BACKGROUND
PMID: 38613553 (View on PubMed)

Other Identifiers

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19978g

Identifier Type: -

Identifier Source: org_study_id

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