Acute Myocardial InfarctionMIRON-CLNCT05898425
Coronary Collaterals and Post-reperfusion Intramyocardial Hemorrhage
An observational study of Acute Myocardial Infarction, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 262 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2022to 17 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
- Age 18-85 years
- Index STEMI
- Coronary angiogram with Primary coronary intervention
- No contraindications for Cardiac MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Myocardial Infarction
- Keywords
- Coronary Angiography, Intramyocardial Hemorrhage, Cardiac Magnetic Resonance
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Intramyocardial hemorrhage (IMH)
Collaterals grades (0-III) will be correlated with incidence rate of IMH
Measured: Day 3
Volume of Intramyocardial hemorrhage (IMH)
Collaterals grades (0-III) will be correlated with IMH volume
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start8 Aug 2022
- Primary completion31 Aug 2024
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rohan Dharmakumar, Indiana University
- Investigators
- Rohan Dharmakumar, PhD, Study director, Indiana UniversityKeyur P Vora, MD FACC, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898425
- Sponsor's protocol ID
- 19978c
- Acronym
- MIRON-CL
- Status last verified
- Apr 2025
- First submitted
- 1 Jun 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Coronary Collaterals on Intramyocardial Hemorrhage in AMI Patients
- ClinicalTrials.gov ID
- NCT05898425
- Acronym / sponsor ID
- MIRON-CL / 19978c
- Conditions
- Acute Myocardial Infarction
- Keywords
- Coronary Angiography, Intramyocardial Hemorrhage, Cardiac Magnetic Resonance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Intramyocardial hemorrhage (IMH)
Time frame: Day 3
Collaterals grades (0-III) will be correlated with incidence rate of IMH
Volume of Intramyocardial hemorrhage (IMH)
Time frame: Day 3
Collaterals grades (0-III) will be correlated with IMH volume
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohan Dharmakumar, PhD study director
Indiana University
Keyur P Vora, MD FACC principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Intramyocardial hemorrhage (IMH) (time frame: Day 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.