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MIRON-TROP: Hemorrhagic Myocardial Infarction Diagnosis by Post-reperfusion Troponin

Sponsor
Rohan Dharmakumar (Other)
Overall Status
Recruiting
CT.gov ID
NCT05872308
Collaborator
(none)
30
Enrollment
1
Location
18
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Hemorrhagic Myocardial Infarction Diagnostics With Post-reperfusion Troponin Kinetics
    Actual Study Start Date :
    Jun 1, 2022
    Anticipated Primary Completion Date :
    Nov 30, 2023
    Anticipated Study Completion Date :
    Nov 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic Threshold [48 hours]

      Threshold levels of serum troponin-I level in hemorrhagic infarct vs. non-hemorrhagic infarct

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age ≥ 18 years

    2. Index Anterior wall STEMI, based on:

    3. Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) and

    4. ECG criteria: New or presumed new ST-segment elevation at the J point in two or more contiguous leads with the cut off points ≥0.2 mV in leads V1, V2, V3 or V4 and ≥0.1 mV in other leads OR new left bundle branch block (LBBB)

    5. Coronary angiogram with evidence of total or subtotal occlusion of the left anterior descending coronary artery (LAD)

    6. Coronary angiogram with PCI to occur irrespective of the onset of the symptoms.

    7. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IU Methodist Hospital Indianapolis Indiana United States 46202

    Sponsors and Collaborators

    • Rohan Dharmakumar

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rohan Dharmakumar, Executive Director, Krannert Cardiovascular Research Center, Indiana University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT05872308
    Other Study ID Numbers:
    • 13081
    First Posted:
    May 24, 2023
    Last Update Posted:
    May 30, 2023
    Last Verified:
    May 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
    Keywords provided by Rohan Dharmakumar, Executive Director, Krannert Cardiovascular Research Center, Indiana University School of Medicine
    STEMI
    Troponin
    Intramyocardial Hemorrhage
    Cardiac MRI
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of May 30, 2023