Hemorrhagic Myocardial Infarction Detection by Biomarkers

Acute Myocardial Infarction Clinical Trial

— MIRON-TROP  

Official title:

Hemorrhagic Myocardial Infarction Detection With Biomarkers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05872308
• Other study ID #: 13081
• Status: Recruiting
• Start date: July 8, 2022
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: Chandana Saha, PhD
• Phone: 317 274 0985
• Email: csaha[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
India	Synergy Superspecialty Hospital	Rajkot
United States	IU Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Threshold	Levels of markers in hemorrhagic infarct vs. non-hemorrhagic infarct	48 hours
Secondary	Peak levels of serum troponin-I	peak levels of serum troponin-I in hemorrhagic infarct vs non-hemorrhagic infarct	48 hours
Secondary	Area under the curve (AUC) for serum troponin-I	area under the curve post-MI for troponin-I	48 hours
Secondary	Hemorrhagic infarct size	as determined by cardiac MRI	48 hours
Secondary	Hemorrhagic infarct volume	as determined by cardiac MRI	48 hours
Secondary	Hemorrhagic infarct microvascular obstruction	as determined by cardiac MRI	48 hours
Secondary	Hemorrhagic infarct area at risk	as determined by cardiac MRI	48 hours