Femoral vs Radial Approach and MRI Evaluation of Strokes

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT00329979
First received: May 23, 2006
Last updated: June 9, 2010
Last verified: June 2010
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 23, 2006
Last Updated: June 9, 2010
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on October 19, 2014