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Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00312624
First received: April 6, 2006
Last updated: June 9, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Cardiomyopathy
 Procedure: contrast-enhanced cardiac MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Estimated Enrollment: 50
Study Start Date: April 2006
Study Completion Date: December 2008
Intervention Details:
    Procedure: contrast-enhanced cardiac MRI
    MRI of heart with delayed enhancement
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients with cardiomyopathy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00312624

Locations
United States, Pennsylvania
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Samir Saba, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Samir Saba/Director, Cardiac electrophysiology, UPMC
ClinicalTrials.gov Identifier: NCT00312624     History of Changes
Other Study ID Numbers: 0602085, 0602085
Study First Received: April 6, 2006
Last Updated: June 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
ICD implantation
cardiac MRI
cardiomyopathy
 ventricular arrhythmias
LVEF 35% or less
indication for ICD implantation as part of standard of care

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Death
Cardiomyopathies
Heart Arrest
 Heart Diseases
Cardiovascular Diseases
Death, Sudden
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013