Femoral vs Radial Approach and MRI Evaluation of Strokes

NCT00329979 | Completed

• 2 other identifiers: 2006-18No additional Ids
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Keywords

aortic stenosis; radial; femoral; vascular access site; embolism; cerebral; MRI; stroke

Study Arms (2)

1

Radial access

Behavioral: vascular access site

2

Femoral access

Behavioral: vascular access site

Interventions

vascular access site BEHAVIORAL

Randomized vascular access site

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with aortic stenosis

You may qualify if:

• Patient with significant aortic valve stenosis before planned surgery.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU Caen, cardiology department

Caen, 14033, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Embolism; Stroke

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Embolism and Thrombosis; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Michèle Hamon, MD

  CHU CAEN

  STUDY CHAIR

• Martial Hamon, MD

  CHU CAEN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 23, 2006
• First Posted: May 25, 2006
• Study Start: May 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 10, 2010

Record last verified: 2010-06

Locations

FR (1)