Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

Completed

• Conditions: Cardiomyopathy

• Registration Number: NCT00312624
• Lead Sponsor: University of Pittsburgh

Brief Summary

This is a pilot study to find a correlation between MRI and ICD therapy in patients with known cardiomyopathies, aiming to determine if cardiac scarring identified by MRI correlates with ventricular arrhythmias and the occurrence of ICD therapy.

Detailed Description

This is an observational study over a 3 year period of 50 patients with known cardiomyopathy and LVEF of 35% or less who will have ICD implantation as part of their standard of care. All subjects will undergo a contrast-enhanced cardiac MRI using gadolinium to determine the morphological characteristics of their left ventricle prior to ICD implant. Subjects will not be offered sedation to minimize risk, thus those suffering from claustrophobia will be excluded or dropped from participation. MRI will be evaluated, and subjects will be followed during standard of care device interrogations for 12 months after implant.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-06
• Study First Submitted QC: 2006-04-07
• Study First Posted: 2006-04-10
• Study Completion: 2008-12
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-09
• Last Update Posted: 2011-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• at least 18 years of age
• cardiomyopathy with LVEF 35% or less
• indication for ICD implantation
• able to provide informed consent

Exclusion Criteria

• prior device implantation
• contraindication for MRI (i.e., metallic foreign body)
• claustrophobia
• pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

UPMC Presbyterian Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States