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Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

This study is currently recruiting participants.
Verified by University of Pittsburgh, June 2008

Sponsored by: University of Pittsburgh
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00312624
  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

Genetics Home Reference related topics:   short QT syndrome   

MedlinePlus related topics:   Cardiac Arrest    Cardiomyopathy   

U.S. FDA Resources

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

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   50
Study Start Date:   April 2006
Estimated 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

Contacts
Contact: Samir Saba, MD     412-647-6272     sabas@upmc.edu    
Contact: Pamela M White, RN     412 647-2931     whitepm@upmc.edu    

Locations
United States, Pennsylvania
UPMC Presbyterian Hospital     Recruiting
      Pittsburgh, Pennsylvania, United States, 15213
      Contact: Samir Saba, MD     412-647-6272     sabas@upmc.edu    
      Contact: Pamela M White, RN     412 647-2931     whitepm@upmc.edu    
      Principal Investigator: Samir Saba, MD            
      Principal Investigator: Eathar Razak, MD            
      Sub-Investigator: William Barrington, MD            
      Sub-Investigator: Raveen Bazaz, MD            
      Sub-Investigator: Sandeep Jain, MD            
      Sub-Investigator: David Schwartzman, MD            
      Sub-Investigator: Susan Brode, MD            

Sponsors and Collaborators
University of Pittsburgh

Investigators
Principal Investigator:     Samir Saba, MD     University of Pittsburgh    
  More Information


Responsible Party:   UPMC ( Samir Saba/Director, Cardiac electrophysiology )
Study ID Numbers:   0602085, 0602085
First Received:   April 6, 2006
Last Updated:   June 3, 2008
ClinicalTrials.gov Identifier:   NCT00312624
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

Study placed in the following topic categories:
Death
Heart Diseases
Death, Sudden
Heart Arrest
Death, Sudden, Cardiac
Cardiomyopathies
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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