Cognitive Outcome After Carotid Surgery
調査の概要
状態
条件
詳細な説明
At the present time, large multi-center clinical trials support the use of carotid revascularization for symptomatic carotid stenosis and for asymptomatic carotid stenosis (greater than 60%) to prevent stroke. Guidelines supporting the use of carotid endarterectomy for asymptomatic stenosis are based largely on the Asymptomatic Carotid Atherosclerosis Study (ACAS) which reported a 47% relative risk reduction for ipsilateral stroke or death in patients randomized to surgery compared to best medical management over 5 years. These data were further substantiated by the recent publication of the Medical Research Council Asymptomatic Carotid Surgery (ACST) trial results (1); however, both trials estimated that at least 40 operative procedures were required to prevent a single disabling stroke or death in one patient after 5 years (2). These data underscore the importance of understanding the cognitive risks of carotid revascularization and developing strategies to limit factors that contribute to this risk especially in asymptomatic patients.
The purpose of this study is to better understand the effect of carotid revascularization (using either carotid endarterectomy (CEA) or percutaneous carotid angioplasty and stenting (CAS)) on cognitive outcome by prospectively collecting cerebral blood flow data and cognitive testing data prior to and after carotid revascularization procedures.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
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Massachusetts
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Burlington、Massachusetts、アメリカ、01805
- Lahey Clinic, Inc.
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New York
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Buffalo、New York、アメリカ、14203
- University of Buffalo Neurosurgery (UBNS)
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Stony Brook、New York、アメリカ、11794-8122
- StonyBrook
-
-
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:
- Patients with asymptomatic (defined as no symptoms in past 6 months) carotid stenosis
- Patients with hemodynamically significant carotid artery stenosis (according to CREST criteria: ≥ 60% by angiography, OR ≥ 70% by ultrasound, OR ≥ 80% by CTA or MRA)
Exclusion Criteria:
- Patients with prior large vessel infarct
- Patients with intracranial stenosis
- Patients with major depression
- Patients with Alzheimer disease (clinically defined or Wechsler IQ <80)
- Patients who have had previous ipsilateral carotid surgery
- Patients with baseline dementia defined as: Mini-Mental Status Examination score < 21 OR Mini-Mental score ≥21 AND Baseline HVLT scores more than 3 standard deviations below normal or FAS scores more than 2 standard deviations below normal OR other clinical symptoms that were not as evident on direct cognitive assessment (e.g. sundowning, getting lost while driving).
Note: A control group would be comprised of about 15 patients who meet eligibility criteria as above, but elect to have their condition followed rather than undergo revascularization.
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 |
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Carotid Endarterectomy (CEA)
Surgical Revascularization- Carotid Endarterectomy (CEA)
|
Carotid Angioplasty and Stenting (CAS)
Surgical Revascularization- Carotid Angioplasty and Stenting (CAS)
|
Control Group- Medical Management
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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 |
---|---|---|
Measurement of change in cerebral blood flow from pre-op/baseline to 1 month post-operatively.
時間枠:preoperative/baseline and 1 month postoperative/from baseline
|
Quantitative flow MRA studies will be performed pre-operative and postoperative for those undergoing carotid revascularization surgery.
Those not undergoing surgery will have this test upon study enrollment and approximately 1 month from study enrollment date.
|
preoperative/baseline and 1 month postoperative/from baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Mini Mental Status Exam
時間枠:Pre-operative/baseline
|
A standardized cognitive measure
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Pre-operative/baseline
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Trail Making- Part A
時間枠:Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
|
Standardized cognitive measure that assesses verbal fluency
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Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
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Trail Making- Part B
時間枠:Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
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Standardized cognitive measure that assesses executive functioning
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Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
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Hopkins Verbal Learning Test (HVLT)
時間枠:Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
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Standardized measure to assess new learning and memory
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Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
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D-KEFS Verbal Fluency Test (FAS)
時間枠:Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
|
Standardized measure to assess letter fluency
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Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Zoher Ghogawala, MD、Lahey Clinic, Inc.
出版物と役立つリンク
一般刊行物
- Halliday A, Mansfield A, Marro J, Peto C, Peto R, Potter J, Thomas D; MRC Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group. Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial. Lancet. 2004 May 8;363(9420):1491-502. doi: 10.1016/S0140-6736(04)16146-1. Erratum In: Lancet. 2004 Jul 31;364(9432):416.
- Rothwell PM, Goldstein LB. Carotid endarterectomy for asymptomatic carotid stenosis: asymptomatic carotid surgery trial. Stroke. 2004 Oct;35(10):2425-7. doi: 10.1161/01.STR.0000141706.50170.a7. Epub 2004 Aug 26. No abstract available.
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 (実際)
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。