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

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.

Study Overview

• Status: Completed
• Conditions: Carotid Stenoses
• Intervention / Treatment: Other: New Guidelines

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?

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• Sweden
  • Västerbotten
    • Umeå, Västerbotten, Sweden, 90821
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients with a carotid stenosis >50%, preliminary eligable for CEA in the northern region of Sweden

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ipsilateral Ischemic Stroke Before Carotid Endarterectomy	Ipsilateral ischemic stroke after the presenting event. Only events that occurs within 90 days and before Carotid EndArterectomy (CEA) is used.	Before CEA

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any Stroke Before Carotid Enderarterectomy	Same as primary endpoint, but includes stroke of all types.	Before CEA

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: Per G Wester, Prof.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: August 9, 2007
• First Submitted That Met QC Criteria: August 9, 2007
• First Posted (Estimate): August 10, 2007

Study Record Updates

• Last Update Posted (Estimate): October 23, 2013
• Last Update Submitted That Met QC Criteria: September 16, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Carotid stenosis; Carotid endarterectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: EJ-0418