Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study (ANSYSCAP) (ANSYSCAP)
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|ClinicalTrials.gov Identifier: NCT00514592|
Recruitment Status : Completed
First Posted : August 10, 2007
Results First Posted : September 13, 2013
Last Update Posted : October 23, 2013
|Condition or disease||Intervention/treatment|
|Carotid Stenoses||Other: New Guidelines|
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?
|Study Type :||Observational|
|Actual Enrollment :||230 participants|
|Official Title:||Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2011|
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.
- Ipsilateral Ischemic Stroke Before Carotid Endarterectomy [ Time Frame: Before CEA ]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 ]Same as primary endpoint, but includes stroke of all types.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514592
|Umeå, Västerbotten, Sweden, 90821|
|Principal Investigator:||Per G Wester, Prof.|