Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

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.

Study Overview

• Status: Completed
• Conditions: Cardiomyopathy
• Intervention / Treatment: Procedure: contrast-enhanced cardiac MRI

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with cardiomyopathy

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Samir Saba, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: April 6, 2006
• First Submitted That Met QC Criteria: April 7, 2006
• First Posted (Estimate): April 10, 2006

Study Record Updates

• Last Update Posted (Estimate): June 10, 2011
• Last Update Submitted That Met QC Criteria: June 9, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: ventricular arrhythmias; cardiomyopathy; cardiac MRI; ICD implantation; LVEF 35% or less; indication for ICD implantation as part of standard of care
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Heart Arrest; Death; Cardiomyopathies; Death, Sudden, Cardiac
• Other Study ID Numbers: 0602085