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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06450912
Other study ID # 19978e
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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