Brief Title
Femoral vs Radial Approach and MRI Evaluation of Strokes
Official Title
Silent Cerebral Infarction After Heart Catheterization: A Randomized Comparison of Radial and Femoral Arterial Access.
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.
Study Type
Observational
Condition
Aortic Stenosis
Intervention
vascular access site
Study Arms / Comparison Groups
1
Description: Radial access
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
152
Start Date
May 2006
Completion Date
September 2009
Primary Completion Date
September 2009
Eligibility Criteria
Inclusion Criteria: - Patient with significant aortic valve stenosis before planned surgery. Exclusion Criteria: - Contraindication to MRI or inability to give written informed consent.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Michèle Hamon, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00329979
Organization ID
2006-18
Secondary IDs
No additional Ids
Study Sponsor
University Hospital, Caen
Study Sponsor
Michèle Hamon, MD, Study Chair, CHU Caen
Verification Date
June 2010