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| Descriptive Information Fields | |||||||||
| Brief Title † | Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies | ||||||||
| Official Title † | Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Cohort, Prospective | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Cardiomyopathy | ||||||||
| Intervention † | Procedure: contrast-enhanced cardiac MRI | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 50 | ||||||||
| Start Date † | April 2006 | ||||||||
| Completion Date | December 2008 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00312624 | ||||||||
| Organization ID | 0602085 | ||||||||
| Secondary IDs †† | 0602085 | ||||||||
| Study Sponsor † | University of Pittsburgh | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | University of Pittsburgh | ||||||||
| Verification Date | June 2008 | ||||||||
| First Received Date † | April 6, 2006 | ||||||||
| Last Updated Date | June 3, 2008 | ||||||||
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