Hemorrhagic Myocardial Infarction Diagnosis by Post-reperfusion Troponin

Hemorrhagic Myocardial Infarction Diagnosis by Post-reperfusion Troponin

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

Go to 

Brief Summary:
Pilot trial to determine diagnostic efficacy of post-reperfusion troponin kinetics in detection of hemorrhagic myocardial infarction

Acute Myocardial Infarction

Go to 

Layout table for study information

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

Go to 

Go to 

Primary Outcome Measures :

Diagnostic Threshold [ Time Frame: 48 hours ]
Threshold levels of serum troponin-I level in hemorrhagic infarct vs. non-hemorrhagic infarct

Go to 

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.

Layout table for eligibility information

Ages Eligible for Study:  
18 Years to 75 Years   (Adult, Older Adult)

Sexes Eligible for Study:  
All

Accepts Healthy Volunteers:  
No

Sampling Method:  
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.

Go to 

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

Layout table for location contacts

Contact: Keyur Vora, MD MSc FACC
317 274 0975
kpvora@iu.edu

Layout table for location information

IU Methodist Hospital

Indianapolis, Indiana, United States, 46202

Rohan Dharmakumar

Go to 

Layout table for additonal information

Responsible Party:
Rohan Dharmakumar, Executive Director, Krannert Cardiovascular Research Center, Indiana University School of Medicine

ClinicalTrials.gov Identifier:
NCT05872308    

Other Study ID Numbers:
13081

First Posted:
May 24, 2023    Key Record Dates

Last Update Posted:
May 24, 2023

Last Verified:
May 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:
No

Layout table for additional information

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:

Layout table for MeSH terms

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.

May 25, 2023Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
Comments