Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study (ANSYSCAP)

Study Overview
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Brief Summary
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A single center observational study. Observing the time between cerebrovascular symptoms and Carotid Endarterectomy (CEA) and patient outcome. An intervention at 17 of the 29 study months aimed at reducing the delay and increasing the patient safety. Main outcome is to measure the reduction in recurrent stroke with decreased delay to CEA.

Detailed Description
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All patients with a carotid stenosis >50% according to the NASCET-criteria are included. The study does not affect the health care the patients receive. The time between symptom and surgery is compared to the outcome of the CEA after 45 days, 6 months, 1 year and 5 years. An intervention in the form of new practical local and regional guidelines in January 2009 (#17 of the 29 study months) aimed at reducing the delay and increasing the patient safety. PRIMARY AIM: To study the risk of Ipsilateral stroke, any stroke, death, any cerebrovascular event, any cardiovascular event. Two primary analyses: Ipsilateral ischemic stroke within 90 Days of the presenting event. This analysis is aimed at the short term risk of pre-operative stroke. Survival analysis will be used. CEA will be used a censor, thus excluding all peri-operative and postoperative strokes. All primary endpoints within 5 years of the presenting event. This analysis is aimed att the long term risk of cardio-vascular morbidity and mortality. Secondary analyses: 1) Same as first primary analysis, but including all stroke as endpoint, not only ipsilateral ischemic stroke. SECONDARY AIM: To attempt to validate different risk and score systems already published by other sources. Such as can ABCD2-score be used safely to chose between acute and fast normal screening for carotid stenosis?

Official Title
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Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study

Conditions
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Carotid Stenoses

Intervention / Treatment
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* Other: New Guidelines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Carotid stenosis >50% according to NASCET criteria Exclusion Criteria: Not preliminary judged as having an indication for surgery, before an extensive investigation is launched. Thus, some patients that will not undergo CEA will be included.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All<br>All patients enter the same group | Other: New Guidelines<br>* New practical guidelines after half of the study aimed at reducing the delay and increasing the patient safety.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ipsilateral Ischemic Stroke Before Carotid Endarterectomy | Ipsilateral ischemic stroke after the presenting event. Only events that occurs within 90 days and before Carotid EndArterectomy (CEA) is used. | Before CEA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any Stroke Before Carotid Enderarterectomy | Same as primary endpoint, but includes stroke of all types. | Before CEA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid stenosis, Carotid endarterectomy