ClinicalTrials.gov
ClinicalTrials.gov Menu

Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00312624
Recruitment Status : Completed
First Posted : April 10, 2006
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
University of Pittsburgh

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment
Cardiomyopathy 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies
Study Start Date : April 2006
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Samir Saba/Director, Cardiac electrophysiology, UPMC
ClinicalTrials.gov Identifier: NCT00312624     History of Changes
Other Study ID Numbers: 0602085
0602085
First Posted: April 10, 2006    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011

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:
Cardiomyopathies
Death
Death, Sudden, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden