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MIRON-CCL: Coronary Collaterals and Post-reperfusion Intramyocardial Hemorrhage

Sponsor
Rohan Dharmakumar (Other)
Overall Status
Recruiting
CT.gov ID
NCT05898425
Collaborator
(none)
200
Enrollment
1
Location
23.9
Anticipated Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study examines the relationship between angiographic coronary collateral grades (Rentrop grades) during acute myocardial infarction and post-reperfusion intramyocardial hemorrhage volume by cardiac magnetic resonance. This study aims to assess the impact of coronary collateral circulation on intramyocardial hemorrhage incidence and extent.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Coronary Collaterals on Post-reperfusion Intramyocardial Hemorrhage in AMI Patients
    Actual Study Start Date :
    Aug 1, 2021
    Anticipated Primary Completion Date :
    Jul 30, 2023
    Anticipated Study Completion Date :
    Jul 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Intramyocardial hemorrhage (IMH) [Post-PCI Day 3]

      Collaterals grades (0-III) will be correlated with incidence rate of IMH

    2. Volume of Intramyocardial hemorrhage (IMH) [Post-PCI Day 3]

      Collaterals grades (0-III) will be correlated with IMH volume

    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 STEMI, based on ACC/AHA criteria

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IU Methodist Hospital Indianapolis Indiana United States 46032

    Sponsors and Collaborators

    • Rohan Dharmakumar

    Investigators

    • Principal Investigator: Keyur Vora, MD FACC, Faculty

    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, Indiana University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT05898425
    Other Study ID Numbers:
    • 14994
    First Posted:
    Jun 12, 2023
    Last Update Posted:
    Jun 12, 2023
    Last Verified:
    Jun 1, 2023
    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, Indiana University School of Medicine
    Acute Myocardial Infarction, Coronary Collaterals, Intramyocardial Hemorrhage, Cardiac Magnetic Resonance
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction
    Hemorrhage

    Study Results

    No Results Posted as of Jun 12, 2023