Femoral vs Radial Approach and MRI Evaluation of Strokes

NCT ID: NCT00329979

Last Updated: 2010-06-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 152 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-09-30

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.

Conditions

Aortic Stenosis

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

1

Radial access

vascular access site

Intervention Type: BEHAVIORAL

Randomized vascular access site

2

Femoral access

vascular access site

Intervention Type: BEHAVIORAL

Randomized vascular access site

Interventions

vascular access site

Randomized vascular access site

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

University hospital, Caen

Principal Investigators

Michèle Hamon, MD

Role: STUDY_CHAIR

CHU CAEN

Martial Hamon, MD

Role: PRINCIPAL_INVESTIGATOR

CHU CAEN

Locations

CHU Caen, cardiology department

Caen, , France

Countries

France

Other Identifiers

No additional Ids

Identifier Type: -

Identifier Source: secondary_id

2006-18

Identifier Type: -

Identifier Source: org_study_id