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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elias Johansson, Umeå University
ClinicalTrials.gov Identifier:
NCT00514592
First received: August 9, 2007
Last updated: September 16, 2013
Last verified: September 2013
  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

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Ipsilateral Ischemic Stroke Before Carotid Endarterectomy [ Time Frame: Before CEA ] [ Designated as safety issue: No ]
    Ipsilateral ischemic stroke after the presenting event. Only events that occurs within 90 days and before Carotid EndArterectomy (CEA) is used.


Secondary Outcome Measures:
  • Any Stroke Before Carotid Enderarterectomy [ Time Frame: Before CEA ] [ Designated as safety issue: No ]
    Same as primary endpoint, but includes stroke of all types.


Enrollment: 230
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, 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?

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Elias Johansson, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT00514592     History of Changes
Other Study ID Numbers: EJ-0418
Study First Received: August 9, 2007
Results First Received: July 8, 2013
Last Updated: September 16, 2013
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 July 29, 2014