Hemorrhagic Myocardial Infarction Detection by Post-reperfusion Troponin Kinetics

NCT ID: NCT05872308

Last Updated: 2025-09-08

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

227 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-08

Study Completion Date

2025-01-21

Brief Summary

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Pilot trial to determine diagnostic efficacy of post-reperfusion troponin kinetics in detection of hemorrhagic myocardial infarction

Detailed Description

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Conditions

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Acute Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years
2. Index STEMI
3. Coronary angiogram with PCI to occur irrespective of the onset of the symptoms.
4. Ability to provide informed consent for themselves

Exclusion Criteria

1. History of prior myocardial infarction,
2. Cardiogenic shock,
3. Patients who present with current cardiac arrest
4. Any contraindication to cardiac CMR (claustrophobia, pacemaker or cardiac defibrillator, known allergy to gadolinium),
5. Presence of permanent atrial fibrillation,
6. Unconscious patient,
7. Severe renal insufficiency (creatinine clearance ≤ 30 ml/min/m2 or renal replacement therapy),
8. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test.
Minimum Eligible Age

18 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

Vice Chair of Research, Medical Imaging Research Institute

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Keyur P Vora, MD FACC

Role: PRINCIPAL_INVESTIGATOR

Faculty

Locations

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IU Methodist Hospital

Indianapolis, Indiana, United States

Site Status

Synergy Cardiovascular Research Center, Synergy Superspecialty Hospital

Rajkot, Gujarat, India

Site Status

Countries

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United States India

References

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Vora KP, Kalra A, Shah CD, Bhatt K, Kumar A, Pandya T, Poptani V, Chan SF, Singh D, Jambunathan N, Subramanian R, Youssef K, Kanakasabai S, Finney R, Desai A, Kreutz RP, Kovacs RJ, Raman SV, Bhatt DL, Dharmakumar R. In-Hospital Mortality in Hemorrhagic Myocardial Infarction. NEJM Evid. 2025 Sep;4(9):EVIDoa2400294. doi: 10.1056/EVIDoa2400294. Epub 2025 Aug 26.

Reference Type DERIVED
PMID: 40858097 (View on PubMed)

Other Identifiers

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13081

Identifier Type: -

Identifier Source: org_study_id

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