NCT00514592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

September 13, 2013

Completed
Last Updated

October 23, 2013

Status Verified

September 1, 2013

Enrollment Period

2.6 years

First QC Date

August 9, 2007

Results QC Date

July 8, 2013

Last Update Submit

September 16, 2013

Conditions

Keywords

Carotid stenosisCarotid endarterectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Any Stroke Before Carotid Enderarterectomy

    Before CEA

Study Arms (1)

All

All patients enter the same group

Other: New Guidelines

Interventions

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

All

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Carotid stenosis \>50% according to NASCET criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Umeå, Västerbotten County, 90821, Sweden

Location

Related 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. doi: 10.1016/S0140-6736(04)15785-1.

    PMID: 15043958BACKGROUND

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr Elias Johansson
Organization
Umeå University

Study Officials

  • Per G Wester, Prof.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 9, 2007

First Posted

August 10, 2007

Study Start

August 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2011

Last Updated

October 23, 2013

Results First Posted

September 13, 2013

Record last verified: 2013-09

Locations