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

Carotid Stenoses Clinical Trial

— ANSYSCAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514592
• Other study ID #: EJ-0418
• Status: Completed
• Phase: N/A
• First received: August 9, 2007
• Last updated: September 16, 2013
• Start date: August 2007
• Est. completion date: March 2011

Study information

• Verified date: September 2013
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: March 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Carotid Stenoses
• Carotid Stenosis

Intervention

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

Locations

Country	Name	City	State
Sweden	University Hospital	Umeå	Västerbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Any Stroke Before Carotid Enderarterectomy	Same as primary endpoint, but includes stroke of all types.	Before CEA	No