Carotid Stenoses
Conditions
Keywords
Carotid stenosis, Carotid endarterectomy
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?
Interventions
OTHERNew Guidelines
New practical guidelines after half of the study aimed at reducing the delay and increasing the patient safety.
Sponsors
Umeå University
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ipsilateral Ischemic Stroke Before Carotid Endarterectomy | Before CEA | Ipsilateral ischemic stroke after the presenting event. Only events that occurs within 90 days and before Carotid EndArterectomy (CEA) is used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any Stroke Before Carotid Enderarterectomy | Before CEA | Same as primary endpoint, but includes stroke of all types. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients All patients are in the same group | 230 |
| Total | 230 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 175 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 230 |
| serious Total, serious adverse events | 0 / 230 |
Outcome results
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.
Time frame: Before CEA
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Ipsilateral Ischemic Stroke Before Carotid Endarterectomy | 33 participants |
Secondary
Any Stroke Before Carotid Enderarterectomy
Same as primary endpoint, but includes stroke of all types.
Time frame: Before CEA
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Any Stroke Before Carotid Enderarterectomy | 36 participants |