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
調査の概要
詳細な説明
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?
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Västerbotten
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Umeå、Västerbotten、スウェーデン、90821
- University Hospital
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
All
All patients enter the same group
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New practical guidelines after half of the study aimed at reducing the delay and increasing the patient safety.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Ipsilateral Ischemic Stroke Before Carotid Endarterectomy
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Any Stroke Before Carotid Enderarterectomy
時間枠：Before CEA
|
Same as primary endpoint, but includes stroke of all types.
|
Before CEA
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Per G Wester, Prof.
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
New Guidelinesの臨床試験
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Nanyang Technological UniversityKK Women's and Children's Hospital; Club Rainbow Singapore; Muscular Dystrophy Association Singapore と他の協力者わからない
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Afeka, The Tel-Aviv Academic College of EngineeringHebrew University of Jerusalem完了
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University of PennsylvaniaKarolinska University Hospital; Leiden University Medical Center; Vittore Buzzi Children's Hospital と他の協力者完了
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Istituto Ortopedico RizzoliOrtopedia e Traumatologia - AO Ordine Mauriziano - Torino; Traumatologia dello Sport - Campus... と他の協力者募集
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Paolo CassanoNorth Suffolk Mental Health Association; Mclean Hospital完了