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Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

This study has been completed.
Information provided by:
University of Pittsburgh Identifier:
First received: April 6, 2006
Last updated: June 9, 2011
Last verified: June 2011
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:

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with cardiomyopathy

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00312624

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

Responsible Party: Samir Saba/Director, Cardiac electrophysiology, UPMC Identifier: NCT00312624     History of Changes
Other Study ID Numbers: 0602085
Study First Received: April 6, 2006
Last Updated: June 9, 2011

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

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden processed this record on August 16, 2017