Femoral vs Radial Approach and MRI Evaluation of Strokes

Aortic Stenosis Clinical Trial

Official title:

Silent Cerebral Infarction After Heart Catheterization: A Randomized Comparison of Radial and Femoral Arterial Access.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329979
• Other study ID #: 2006-18
• Secondary ID: No additional Id
• Status: Completed
• Phase: N/A
• First received: May 23, 2006
• Last updated: June 9, 2010
• Start date: May 2006
• Est. completion date: September 2009

Study information

• Verified date: June 2010
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Behavioral:
• vascular access site
Randomized vascular access site

Locations

Country	Name	City	State
France	CHU Caen, cardiology department	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France,