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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.
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:
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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All | All patients enter the same group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Guidelines | Other | New practical guidelines after half of the study aimed at reducing the delay and increasing the patient safety. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Any Stroke Before Carotid Enderarterectomy | Same as primary endpoint, but includes stroke of all types. | Before CEA |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with a carotid stenosis >50%, preliminary eligable for CEA in the northern region of Sweden
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| Name | Affiliation | Role |
|---|---|---|
| Per G Wester, Prof. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Umeå | Västerbotten County | 90821 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15043958 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | All patients enter the same group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | All patients are in the same group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | Before CEA |
|
|
Adverse events not recorded other than the primary and secodary endpoint.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | All patients enter the same group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Elias Johansson | Umeå University | +46907850000 | elias.johansson@neuro.umu.se |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Any Stroke Before Carotid Enderarterectomy | Same as primary endpoint, but includes stroke of all types. | Posted | Number | participants | Before CEA |
|
|
|
| 0 |
| 230 |
| 0 |
| 230 |
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| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |