Carotid Stenoses Clinical Trial
Official title:
Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study
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.
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:
1. 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.
2. 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?
;
Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00514644 -
Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)
|
N/A |