Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329979
Status:
COMPLETED
Last Update Posted:
2010-06-10
First Post:
2006-05-23
Brief Title:
Femoral vs Radial Approach and MRI Evaluation of Strokes
Sponsor:
University Hospital Caen
Organization:
University Hospital Caen
Study Overview
Official Title:
Silent Cerebral Infarction After Heart Catheterization A Randomized Comparison of Radial and Femoral Arterial Access
Status:
COMPLETED
Status Verified Date:
2010-06
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:
Symptomatic cerebral infarction following cardiac catheterization is rare but silent brain injury could occur at an unexpectedly high rate One study has found that up to 22 of patients with severe aortic stenosis who have undergone retrograde catheterization of the valve can be identified as having new ischemic lesions as detected by diffusion-weighted DW magnetic resonance imaging MRI During cardiac catheterization cerebral microembolism as detected by TCD has frequently been observed but whether it is clinically relevant remains unknown However recent studies have suggested that some of these microemboli could be responsible for acute brain injury as documented by DW MRI
Indeed the high sensitivity of DW MRI suggests that this technique could allow an improved estimate of cerebral ischemic events associated with cardiovascular-catheter procedures We therefore decided to perform DW MRI before and after cardiac catheterization to prospectively assess both clinically silent and apparent cerebral embolisms for the first time in a multicenter trial Furthermore a randomization between radial and femoral access will allow assessment of risk of silent brain injury associated with the different vascular access sites
Indeed the high sensitivity of DW MRI suggests that this technique could allow an improved estimate of cerebral ischemic events associated with cardiovascular-catheter procedures We therefore decided to perform DW MRI before and after cardiac catheterization to prospectively assess both clinically silent and apparent cerebral embolisms for the first time in a multicenter trial Furthermore a randomization between radial and femoral access will allow assessment of risk of silent brain injury associated with the different vascular access sites
Detailed Description:
None
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 |
|---|---|---|---|
| No additional Ids | None | None | None |