Femoral vs Radial Approach and MRI Evaluation of Strokes

Completed

• Conditions: Aortic Stenosis
• Interventions: Behavioral: vascular access site

• Registration Number: NCT00329979
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-23
• Study First Submitted QC: 2006-05-23
• Study First Posted: 2006-05-25
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-09
• Last Update Posted: 2010-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• Patient with significant aortic valve stenosis before planned surgery.

Exclusion Criteria

• Contraindication to MRI or inability to give written informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	vascular access site	Radial access
2	vascular access site	Femoral access

Trial Locations

Locations (1)

CHU Caen, cardiology department; 🇫🇷 Caen, France