Wall Strain Index Ratio as a Biomarker for Mechanical Complication of Hemorrhagic Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— MIRON-STRAIN  

Official title:

Wall Strain Index Ratio as a Biomarker for Mechanical Complication of Hemorrhagic MI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06450912
• Other study ID #: 19978e
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hemorrhagic Myocardial infarctions are at high risk for mechanical complications including cardiac rupture. Prediction of vulnerable myocardial segments is an important step for the stratification of hemorrhagic MI patients. Wall motion index ratio is an important parameter to determine regions of high vulnerability within the 17-segment LV model of hemorrhagic MI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Index STEMI

• Primary PCI

• Able to complete Cardiac MR - STRAIN Protocol

Exclusion Criteria:

• Contraindication to CMR (Contrast Hypersensitivity, Metallic Implants, Abnormal Rhythms, breathing difficulties)

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Hemorrhage
• Infarction
• Myocardial Infarction
• Myocardial Reperfusion Injury
• Myocardial Stunning
• Reperfusion Injury
• Rupture

Locations

Country	Name	City	State
United States	Krannert Cardiovascular Research Center, Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Rohan Dharmakumar

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wall Strain Index for Potential Detection of Intramyocardial Hemorrhage	Difference in Wall Strain Index values between patients with intramyocardial hemorrhage and those without, confirmed by cardiac MRI.	48 hours Post-PCI
Primary	Wall Strain Index in Detecting the Severity of Intramyocardial Hemorrhage	Relationship between initial Wall Strain Index measurements and the volume of intramyocardial hemorrhage quantified by cardiac MRI	48 hours Post-PCI
Primary	Wall Strain Index Ratio in Identification of Vulnerable LV Segments for Cardiac Rupture	Wall Strain Index Ratio for circumferential and longitudinal strain in identifying vulnerable hemorrhagic left ventricular segments at risk for rupture	48 hours Post-PCI