Novel Imaging Biomarkers for Mechanical Complications in Acute Myocardial Infarction

NCT06450912 | Completed

• 1 other identifier: 19978e
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myocardial Infarction; Myocardial Rupture (Post Infarct); Hemorrhagic Myocardial Infarction; Myocardial Stunning; Myocardial Hemorrhage; Myocardial Reperfusion Injury

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of individuals aged 18 to 80 who have been diagnosed with acute ST-elevation myocardial infarction (STEMI) and are scheduled for emergency percutaneous coronary intervention (PCI).

You may qualify if:

• Index STEMI
• Primary PCI
• Able to complete Cardiac MR - STRAIN Protocol

You may not qualify if:

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

Sponsors & Collaborators

• Rohan Dharmakumar: lead

Study Sites (1)

Krannert Cardiovascular Research Center, Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Myocardial Stunning; Myocardial Reperfusion Injury; Heart Rupture, Post-Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiomyopathies; Myocardial Ischemia; Vascular Diseases; Reperfusion Injury; Postoperative Complications; Pathologic Processes; Heart Rupture

Study Officials

• Rohan Dharmakumar, PhD

  Indiana University School of Medicine

  STUDY DIRECTOR

• Keyur P Vora, MD FACC

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director, Krannert Cardiovascular Research Center

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)