Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study (ANSYSCAP) (ANSYSCAP)
Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study
研究概览
详细说明
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:
- 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.
- 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?
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Västerbotten
-
Umeå、Västerbotten、瑞典、90821
- University Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
All
All patients enter the same group
|
New practical guidelines after half of the study aimed at reducing the delay and increasing the patient safety.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Ipsilateral Ischemic Stroke Before Carotid Endarterectomy
大体时间:Before CEA
|
Ipsilateral ischemic stroke after the presenting event.
Only events that occurs within 90 days and before Carotid EndArterectomy (CEA) is used.
|
Before CEA
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Any Stroke Before Carotid Enderarterectomy
大体时间:Before CEA
|
Same as primary endpoint, but includes stroke of all types.
|
Before CEA
|
合作者和调查者
调查人员
- 首席研究员:Per G Wester, Prof.
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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