- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05898425
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
Conditions
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
- Age ≥ 18 years
- Index STEMI
- Coronary angiogram with PCI
- 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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19978c
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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