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

Completed
Conditions
Carotid Stenoses
Interventions
Other: New Guidelines
Registration Number
NCT00514592
Lead Sponsor
Umeå University
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?

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
230
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
AllNew GuidelinesAll patients enter the same group
Primary Outcome Measures
NameTimeMethod
Ipsilateral Ischemic Stroke Before Carotid EndarterectomyBefore CEA

Ipsilateral ischemic stroke after the presenting event. Only events that occurs within 90 days and before Carotid EndArterectomy (CEA) is used.

Secondary Outcome Measures
NameTimeMethod
Any Stroke Before Carotid EnderarterectomyBefore CEA

Same as primary endpoint, but includes stroke of all types.

Trial Locations

Locations (1)

University Hospital

🇸🇪

Umeå, Västerbotten, Sweden

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