The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05898425
Recruitment Status : **RECRUITING NOW**
First Posted : June 12, 2023
Last Update Posted : June 12, 2023
Sponsor:
Information provided by (Responsible Party):
Rohan Dharmakumar, Indiana University School of Medicine
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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.
Acute Myocardial Infarction
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Study Type :
Observational [Patient Registry]
Estimated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Target Follow-Up Duration:
5 Years
Official Title:
Impact of Coronary Collaterals on Post-reperfusion Intramyocardial Hemorrhage in AMI Patients
Actual Study Start Date :
August 1, 2021
Estimated Primary Completion Date :
July 30, 2023
Estimated Study Completion Date :
July 30, 2023
Resource links provided by the National Library of Medicine
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Primary Outcome Measures :
Incidence of Intramyocardial hemorrhage (IMH) [ Time Frame: Post-PCI Day 3 ]
Collaterals grades (0-III) will be correlated with incidence rate of IMH
Volume of Intramyocardial hemorrhage (IMH) [ Time Frame: Post-PCI Day 3 ]
Collaterals grades (0-III) will be correlated with IMH volume
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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Ages Eligible for Study: Â
18 Years to 75 Years  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
No
Sampling Method: Â
Non-Probability Sample
The study population comprises individuals aged 18 years or older who are diagnosed with Index STEMI, based on ACC/AHA criteria, and are expected to undergo coronary angiogram with PCI, regardless of symptom onset.
Inclusion Criteria:
Age ≥ 18 years
Index STEMI, based on ACC/AHA criteria
Coronary angiogram with PCI to occur irrespective of the onset of the symptoms.
Ability to provide informed consent for themselves
Exclusion Criteria:
History of prior myocardial infarction,
Cardiogenic shock,
Patients who present with current cardiac arrest
Any contraindication to cardiac CMR (claustrophobia, pacemaker or cardiac defibrillator, known allergy to gadolinium),
Presence of permanent atrial fibrillation,
Unconscious patient,
Severe renal insufficiency (creatinine clearance ≤ 30 ml/min/m2 or renal replacement therapy),
Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test.
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05898425
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Contact: Chandana Saha, PhD
3172740985
csaha@iu.edu
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IU Methodist Hospital
Indianapolis, Indiana, United States, 46032
Contact: Chandana Saha   317-274-0985   csaha@iu.edu  Â
Rohan Dharmakumar
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Principal Investigator:
Keyur Vora, MD FACC
Faculty
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Responsible Party:
Rohan Dharmakumar, Executive Director, Krannert Cardiovascular Research Center, Indiana University School of Medicine, Indiana University School of Medicine
ClinicalTrials.gov Identifier:
NCT05898425 Â Â
Other Study ID Numbers:
14994
First Posted:
June 12, 2023 Â Â Key Record Dates
Last Update Posted:
June 12, 2023
Last Verified:
June 2023
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rohan Dharmakumar, Indiana University School of Medicine:
Acute Myocardial Infarction, Coronary Collaterals, Intramyocardial Hemorrhage, Cardiac Magnetic Resonance
Additional relevant MeSH terms:
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Myocardial InfarctionInfarctionHemorrhageIschemiaPathologic Processes
NecrosisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
