Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-04-02 @ 4:48 AM
Study NCT ID:
NCT00514592
Status:
COMPLETED
Last Update Posted:
2013-10-23
First Post:
2007-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study (ANSYSCAP)
Sponsor:
Umeå University
Organization:
Study Overview
Official Title:
Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANSYSCAP
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.
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?
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: