Femoral vs Radial Approach and MRI Evaluation of Strokes

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis
• Intervention / Treatment: Behavioral: vascular access site

• Study Type: Observational
• Enrollment (Anticipated): 152

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • CHU Caen, cardiology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with aortic stenosis

Description

Inclusion Criteria:

• Patient with significant aortic valve stenosis before planned surgery.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Radial access	Behavioral: vascular access site; Randomized vascular access site
2; Femoral access	Behavioral: vascular access site; Randomized vascular access site

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Study Chair: Michèle Hamon, MD, CHU Caen; Principal Investigator: Martial Hamon, MD, CHU Caen

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: May 23, 2006
• First Submitted That Met QC Criteria: May 23, 2006
• First Posted (Estimate): May 25, 2006

Study Record Updates

• Last Update Posted (Estimate): June 10, 2010
• Last Update Submitted That Met QC Criteria: June 9, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: MRI; stroke; embolism; aortic stenosis; radial; femoral; vascular access site; cerebral
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2006-18; no additional IDs

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No