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: NCT05872308
Recruitment Status : **RECRUITING NOW**
First Posted : May 24, 2023
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
Rohan Dharmakumar, Indiana University School of Medicine
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Brief Summary:
Pilot trial to determine diagnostic efficacy of post-reperfusion troponin kinetics in detection of hemorrhagic myocardial infarction
Acute Myocardial Infarction
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Study Type :
Observational
Estimated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Hemorrhagic Myocardial Infarction Diagnostics With Post-reperfusion Troponin Kinetics
Actual Study Start Date :
June 1, 2022
Estimated Primary Completion Date :
November 30, 2023
Estimated Study Completion Date :
November 30, 2023
Resource links provided by the National Library of Medicine
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Primary Outcome Measures :
Diagnostic Threshold [ Time Frame: 48 hours ]
Threshold levels of serum troponin-I level in hemorrhagic infarct vs. non-hemorrhagic infarct
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Information from the National Library of Medicine
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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 consists of individuals aged 18 to 75 who have been diagnosed with acute ST-elevation myocardial infarction (STEMI) presenting to ER within 12 hours of symptom onset and are scheduled for emergency percutaneous coronary intervention (PCI).
Inclusion Criteria:
Age ≥ 18 years
Index Anterior wall STEMI, based on:
Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) and
ECG criteria: New or presumed new ST-segment elevation at the J point in two or more contiguous leads with the cut off points ≥0.2 mV in leads V1, V2, V3 or V4 and ≥0.1 mV in other leads OR new left bundle branch block (LBBB)
Coronary angiogram with evidence of total or subtotal occlusion of the left anterior descending coronary artery (LAD)
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): NCT05872308
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Contact: Keyur Vora, MD MSc FACC
317 274 0975
kpvora@iu.edu
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IU Methodist Hospital
Indianapolis, Indiana, United States, 46202
Rohan Dharmakumar
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Responsible Party:
Rohan Dharmakumar, Executive Director, Krannert Cardiovascular Research Center, Indiana University School of Medicine
ClinicalTrials.gov Identifier:
NCT05872308 Â Â
Other Study ID Numbers:
13081
First Posted:
May 24, 2023 Â Â Key Record Dates
Last Update Posted:
May 24, 2023
Last Verified:
May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
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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:
STEMI, Troponin, Intramyocardial Hemorrhage, Cardiac MRI
Additional relevant MeSH terms:
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Myocardial InfarctionInfarctionIschemiaPathologic ProcessesNecrosis
Myocardial 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.
