Femoral vs Radial Approach and MRI Evaluation of Strokes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00329979
Recruitment Status : Completed
First Posted : May 25, 2006
Last Update Posted : June 10, 2010
Information provided by:
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.

Condition or disease Intervention/treatment
Aortic Stenosis Behavioral: vascular access site

Study Type : Observational
Estimated Enrollment : 152 participants
Time Perspective: Prospective
Official Title: Silent Cerebral Infarction After Heart Catheterization: A Randomized Comparison of Radial and Femoral Arterial Access.
Study Start Date : May 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Radial access
Behavioral: vascular access site
Randomized vascular access site
Femoral access
Behavioral: vascular access site
Randomized vascular access site

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with aortic stenosis

Inclusion Criteria:

  • Patient with significant aortic valve stenosis before planned surgery.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00329979

CHU Caen, cardiology department
Caen, France, 14033
Sponsors and Collaborators
University Hospital, Caen
Study Chair: Michèle Hamon, MD CHU Caen
Principal Investigator: Martial Hamon, MD CHU Caen

Responsible Party: Patrick MICHEL, research and strategy manager, University hospital, Caen Identifier: NCT00329979     History of Changes
Other Study ID Numbers: 2006-18
No additional Ids
First Posted: May 25, 2006    Key Record Dates
Last Update Posted: June 10, 2010
Last Verified: June 2010

Keywords provided by University Hospital, Caen:
aortic stenosis
vascular access site

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction