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Femoral vs Radial Approach and MRI Evaluation of Strokes

NCT00329979 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 152

Last updated 2010-06-10

No results posted yet for this study

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

Interventions

BEHAVIORAL

vascular access site

Randomized vascular access site

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • Michèle Hamon, MD · CHU CAEN

  • Martial Hamon, MD · CHU CAEN

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00329979 on ClinicalTrials.gov