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

This study has been completed.
Sponsor:
Information provided by:
Umeå University
ClinicalTrials.gov Identifier:
NCT00514592
First received: August 9, 2007
Last updated: June 3, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Carotid Stenoses
 Other: New Guidelines

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study

Further study details as provided by Umeå University:

Estimated Enrollment: 350
Study Start Date: August 2007
Study Completion Date: March 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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 and 1 year. 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 endpoints: Ipsilateral stroke, any stroke, death, any cerebrovascular event.

Secondary endpoints: 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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514592

Locations
Sweden
University Hospital
Umeå, Västerbotten, Sweden, 90821
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Per G Wester, Prof.
  More Information

Publications:

Responsible Party: Per Wester, Umeå University
ClinicalTrials.gov Identifier: NCT00514592     History of Changes
Other Study ID Numbers: EJ-0418
Study First Received: August 9, 2007
Last Updated: June 3, 2011
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Umeå University:
Carotid stenosis
Carotid endarterectomy

Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013