Clinical trial NCT00514592: Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study (ANSYSCAP)
Official title: Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Stenoses
Keywords: Carotid stenosis
Carotid endarterectomy
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2007-08-10
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with a carotid stenosis \>50%, preliminary eligable for CEA in the northern region of Sweden

Brief summary: 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: 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?

Eligibility criteria: 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.

Primary outcomes:
measure: Ipsilateral Ischemic Stroke Before Carotid Endarterectomy
timeFrame: Before CEA
Secondary outcomes:
measure: Any Stroke Before Carotid Enderarterectomy
timeFrame: Before CEA
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: University Hospital
state: Västerbotten
Study officials:
name: Per G Wester, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rothwell PM, Eliasziw M, Gutnikov SA, Warlow CP, Barnett HJ; Carotid Endarterectomy Trialists Collaboration. Endarterectomy for symptomatic carotid stenosis in relation to clinical subgroups and timing of surgery. Lancet. 2004 Mar 20;363(9413):915-24. doi: 10.1016/S0140-6736(04)15785-1.