Coronary Collaterals and Post-reperfusion Intramyocardial Hemorrhage (MIRON-CCL)

February 2, 2024 updated by: Rohan Dharmakumar, Indiana University

Impact of Coronary Collaterals on Intramyocardial Hemorrhage in AMI Patients

This study examines the relationship between angiographic coronary collaterals (Rentrop grades) and post-reperfusion microvascular injury. This study aims to assess the impact of coronary collateral circulation on intramyocardial hemorrhage incidence and extent.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chandana Saha, PhD
  • Phone Number: 3172740985
  • Email: csaha@iu.edu

Study Locations

    • Indiana
      • Indianapolis, Indiana, United States, 46032
        • Recruiting
        • IU Methodist Hospital
        • Contact:
          • Chandana Saha
          • Phone Number: 317-274-0985
          • Email: csaha@iu.edu
        • Principal Investigator:
          • Keyur P Vora, MD FACC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population comprises individuals aged 18 years or older who are diagnosed with Index STEMI, based on ACC/AHA criteria, and have completed coronary angiogram with PCI and CMR.

Description

  1. Age ≥ 18 years
  2. Index STEMI
  3. Coronary angiogram with PCI
  4. Cardiac MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Intramyocardial hemorrhage (IMH)
Time Frame: Day 3
Collaterals grades (0-III) will be correlated with incidence rate of IMH
Day 3
Volume of Intramyocardial hemorrhage (IMH)
Time Frame: Day 3
Collaterals grades (0-III) will be correlated with IMH volume
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Keyur Vora, MD FACC, Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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