Femoral vs Radial Approach and MRI Evaluation of Strokes
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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. |
| 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 |
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.
Contacts and Locations| France | |
| CHU Caen, cardiology department | |
| Caen, France, 14033 | |
| 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 Cerebral Infarction Constriction, Pathologic Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction Brain Infarction |
Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Stroke Vascular Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 23, 2013