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| 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 |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies |
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | December 2008 |
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 |
patients with cardiomyopathy
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Samir Saba, MD | 412-647-6272 | sabas@upmc.edu |
| Contact: Pamela M White, RN | 412 647-2931 | whitepm@upmc.edu |
| 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 | |
| Principal Investigator: | Samir Saba, MD | University of Pittsburgh |
More Information
| Responsible Party: | UPMC ( Samir Saba/Director, Cardiac electrophysiology ) |
| Study ID Numbers: | 0602085, 0602085 |
| Study First Received: | April 6, 2006 |
| Last Updated: | June 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00312624 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
ICD implantation cardiac MRI cardiomyopathy |
ventricular arrhythmias LVEF 35% or less indication for ICD implantation as part of standard of care |
|
Death Heart Diseases Death, Sudden Heart Arrest |
Death, Sudden, Cardiac Cardiomyopathies Arrhythmias, Cardiac |
|
Death Pathologic Processes Heart Diseases Death, Sudden |
Cardiovascular Diseases Heart Arrest Death, Sudden, Cardiac Cardiomyopathies |
