- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06450912
Novel Imaging Biomarkers for Mechanical Complications in Acute Myocardial Infarction (MIRON-RUPTURE)
January 12, 2026 updated by: Rohan Dharmakumar
WSI Ratio as a Biomarker for Mechanical Complication of Hemorrhagic MI
Hemorrhagic Myocardial infarctions are at high risk for mechanical complications including cardiac rupture.
Prediction of vulnerable myocardial segments is an important step for the stratification of hemorrhagic MI patients.
Wall motion index ratio is an important parameter to determine regions of high vulnerability within the 17-segment LV model of hemorrhagic MI.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Krannert Cardiovascular Research Center, Indiana University School of Medicine
-
-
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 consists of individuals aged 18 to 80 who have been diagnosed with acute ST-elevation myocardial infarction (STEMI) and are scheduled for emergency percutaneous coronary intervention (PCI).
Description
Inclusion Criteria:
- Index STEMI
- Primary PCI
- Able to complete Cardiac MR - STRAIN Protocol
Exclusion Criteria:
- Contraindication to CMR (Contrast Hypersensitivity, Metallic Implants, Abnormal Rhythms, breathing difficulties)
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 |
|---|---|---|
|
Wall Strain Index for Potential Detection of Intramyocardial Hemorrhage
Time Frame: 48 hours Post-PCI
|
Difference in Wall Strain Index values between patients with intramyocardial hemorrhage and those without, confirmed by cardiac MRI.
|
48 hours Post-PCI
|
|
Wall Strain Index in Detecting the Severity of Intramyocardial Hemorrhage
Time Frame: 48 hours Post-PCI
|
Relationship between initial Wall Strain Index measurements and the volume of intramyocardial hemorrhage quantified by cardiac MRI
|
48 hours Post-PCI
|
|
Wall Strain Index Ratio in Identification of Vulnerable LV Segments for Cardiac Rupture
Time Frame: 48 hours Post-PCI
|
Wall Strain Index Ratio for circumferential and longitudinal strain in identifying vulnerable hemorrhagic left ventricular segments at risk for rupture
|
48 hours Post-PCI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Keyur P Vora, MD FACC, Indiana University School of Medicine
- Study Director: Rohan Dharmakumar, PhD, Indiana University School of Medicine
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)
June 1, 2022
Primary Completion (Actual)
June 1, 2024
Study Completion (Actual)
June 1, 2024
Study Registration Dates
First Submitted
June 4, 2024
First Submitted That Met QC Criteria
June 7, 2024
First Posted (Actual)
June 10, 2024
Study Record Updates
Last Update Posted (Estimated)
January 14, 2026
Last Update Submitted That Met QC Criteria
January 12, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Postoperative Complications
- Pathologic Processes
- Heart Diseases
- Cardiomyopathies
- Myocardial Ischemia
- Reperfusion Injury
- Heart Rupture
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Myocardial Reperfusion Injury
- Myocardial Stunning
- Heart Rupture, Post-Infarction
Other Study ID Numbers
- 19978e
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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