Hemorrhagic Myocardial Infarction Detection by Biomarkers

Completed

• Conditions: Acute Myocardial Infarction

• Registration Number: NCT05872308
• Lead Sponsor: Indiana University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-08
• Study First Submitted: 2023-05-14
• Study First Submitted QC: 2023-05-14
• Study First Posted: 2023-05-24
• Primary Completion: 2025-01-21
• Study Completion: 2025-01-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

1. Age ≥ 18 years
2. Index STEMI
3. Coronary angiogram with PCI to occur irrespective of the onset of the symptoms.
4. Ability to provide informed consent for themselves

Exclusion Criteria

1. History of prior myocardial infarction,
2. Cardiogenic shock,
3. Patients who present with current cardiac arrest
4. Any contraindication to cardiac CMR (claustrophobia, pacemaker or cardiac defibrillator, known allergy to gadolinium),
5. Presence of permanent atrial fibrillation,
6. Unconscious patient,
7. Severe renal insufficiency (creatinine clearance ≤ 30 ml/min/m2 or renal replacement therapy),
8. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Threshold	48 hours	Levels of markers in hemorrhagic infarct vs. non-hemorrhagic infarct

Secondary Outcome Measures

Name	Time	Method
Peak levels of serum troponin-I	48 hours	peak levels of serum troponin-I in hemorrhagic infarct vs non-hemorrhagic infarct
Hemorrhagic infarct microvascular obstruction	48 hours	as determined by cardiac MRI
Area under the curve (AUC) for serum troponin-I	48 hours	area under the curve post-MI for troponin-I
Hemorrhagic infarct volume	48 hours	as determined by cardiac MRI
Hemorrhagic infarct area at risk	48 hours	as determined by cardiac MRI
Hemorrhagic infarct size	48 hours	as determined by cardiac MRI

Trial Locations

Locations (2)

IU Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Synergy Superspecialty Hospital; 🇮🇳 Rājkot, India