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Femoral vs Radial Approach and MRI Evaluation of Strokes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00329979
First Posted: May 25, 2006
Last Update Posted: June 10, 2010
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.
Information provided by:
University Hospital, Caen
  Purpose

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 Intervention
Aortic Stenosis Behavioral: vascular access site

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Silent Cerebral Infarction After Heart Catheterization: A Randomized Comparison of Radial and Femoral Arterial Access.

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Estimated Enrollment: 152
Study Start Date: May 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Radial access
Behavioral: vascular access site
Randomized vascular access site
2
Femoral access
Behavioral: vascular access site
Randomized vascular access site

  Eligibility

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
Criteria

Inclusion Criteria:

  • Patient with significant aortic valve stenosis before planned surgery.

Exclusion Criteria:

  • Contraindication to MRI or inability to give written informed consent.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00329979


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

Responsible Party: Patrick MICHEL, research and strategy manager, University hospital, Caen
ClinicalTrials.gov Identifier: NCT00329979     History of Changes
Other Study ID Numbers: 2006-18
No additional Ids
First Submitted: May 23, 2006
First Posted: May 25, 2006
Last Update Posted: June 10, 2010
Last Verified: June 2010

Keywords provided by University Hospital, Caen:
aortic stenosis
radial
femoral
vascular access site
embolism
cerebral
MRI
stroke

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