Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study (ANSYSCAP)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study|
- Ipsilateral Ischemic Stroke Before Carotid Endarterectomy [ Time Frame: Before CEA ] [ Designated as safety issue: No ]Ipsilateral ischemic stroke after the presenting event. Only events that occurs within 90 days and before Carotid EndArterectomy (CEA) is used.
- Any Stroke Before Carotid Enderarterectomy [ Time Frame: Before CEA ] [ Designated as safety issue: No ]Same as primary endpoint, but includes stroke of all types.
|Study Start Date:||August 2007|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
All patients enter the same group
Other: New Guidelines
New practical guidelines after half of the study aimed at reducing the delay and increasing the patient safety.
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.
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.
1) Same as first primary analysis, but including all stroke as endpoint, not only ipsilateral ischemic stroke.
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?
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514592
|Umeå, Västerbotten, Sweden, 90821|
|Principal Investigator:||Per G Wester, Prof.|