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

NCT ID: NCT00514592

Last Updated: 2013-10-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-03-31

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?

Conditions

Carotid Stenoses

Keywords

Carotid stenosis; Carotid endarterectomy

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

All

All patients enter the same group

New Guidelines

Intervention Type: OTHER

New practical guidelines after half of the study aimed at reducing the delay and increasing the patient safety.

Interventions

New Guidelines

New practical guidelines after half of the study aimed at reducing the delay and increasing the patient safety.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Elias Johansson

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Per G Wester, Prof.

Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital

Umeå, Västerbotten County, Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 15043958 (View on PubMed)

Other Identifiers

EJ-0418

Identifier Type: -

Identifier Source: org_study_id