Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00312624
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2006-04-06
Brief Title:
Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0602085 | None | None | None |