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NCT00312624 Clinical Trial

Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

Cardiomyopathy Clinical Trial

Official title:
Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00312624
Other study ID # 0602085
Secondary ID 0602085
Status Completed
Phase N/A
First received April 6, 2006
Last updated June 9, 2011
Start date April 2006
Est. completion date December 2008

Study information
Verified date June 2011
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• contrast-enhanced cardiac MRI
MRI of heart with delayed enhancement

Locations
Country Name City State
United States UPMC Presbyterian Hospital Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

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