Vitamin Intervention for Stroke Prevention (VISP)

预防中风的维生素干预 (VISP)

• 批准号: 7168361
• 负责人: JAMES F TOOLE
• 金额: $ 4.71万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-09-15 至 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7168361
• 关键词: cardiovascular disorder chemotherapy; chemoprevention; clinical research; clinical trials; folate; human subject; human therapy evaluation; myocardial infarction; pyridoxine; stroke; vitamin B12; vitamin therapy

EXCEEDTHE SPACE PROVIDED. Elevated plasma levels of homocyst(e)ine [H(e)] are surprisingly common and strongly associated with endothelial dysfunction and a marked increase in vascular risk. Treatment with a combination of folic acid, pyridoxine (vitamin B6) and cobalamin (vitamin B12) reduces plasma H(e) levels in most cases, restores endothelial function, and regresses carotid plaque but there is no evidence that such treatmentwill reduce clinical events. The Vitamin Intervention for Stroke Prevention (VISP) study is adouble-masked, randomized, multi-center clinical trial designed to determine if, in addition to best medical/surgical management, high dose folic acid, vitamin B6, and B,2 supplements will reduce recurrent stroke compared to lower doses of these vitamins. Patients at least 35 years old with a non-disabling ischemic strokewithin 120 days, and screening plasma H(e)> the 25th percentile of benchmark population data are eligible. Secondary endpoints are myocardial infarction or fatal coronary heart disease. The study is designed to recruit 3600 patients (1800 in each treatment group) for 80% power for detection of a 30% treatment effect. Follow-up continues until recurrent stroke, death, or a maximum of two years. As of May 4, 2000, we have screened 4600 candidates for eligibility and have randomized 2395. We are blinded to the outcome of endpoints. Four hundred enrollees have completed the two-year followup. The followup rate is 94%. There have been no insurmountable impediments to implementaion of all the component parts of this study. A supplemental research proposal for use of frozen plasma samples of our cohart for genetic and coogulation studies is in preparation.

超出提供的空间。 令人惊讶的是，血浆同型半胱氨酸 [H(e)] 水平升高非常常见，并且与以下因素密切相关： 内皮功能障碍和血管风险显着增加。叶酸组合治疗 在大多数情况下，酸、吡哆醇（维生素 B6）和钴胺素（维生素 B12）会降低血浆 H(e) 水平， 恢复内皮功能，消退颈动脉斑块，但没有证据表明这种治疗会 减少临床事件。预防中风的维生素干预 (VISP) 研究是一项双重掩盖的研究， 随机、多中心临床试验，旨在确定除了最佳医疗/手术之外是否 管理方面，相比之下，高剂量叶酸、维生素 B6 和 B,2 补充剂将减少中风复发 降低这些维生素的剂量。年龄至少 35 岁且患有非致残性缺血性中风的患者 120天，并且筛选血浆H(e)>基准人群数据的第25个百分位数是合格的。 次要终点是心肌梗塞或致命的冠心病。该研究旨在 招募 3600 名患者（每个治疗组 1800 名），以 80% 的功效检测 30% 的治疗 影响。随访持续至复发性中风、死亡或最长两年。 截至 2000 年 5 月 4 日，我们已经筛选了 4600 名候选人的资格，并随机分配了 2395 名候选人。 对终点的结果视而不见。四百名参与者已完成两年的随访。这 随访率为94%。所有措施的实施均不存在不可克服的障碍 本研究的组成部分。 使用我们实验室的冷冻血浆样本进行遗传和免疫学研究的补充研究提案 凝固研究正在准备中。

项目成果

Vitamin intervention for stroke prevention.

维生素干预预防中风。

• DOI: 10.1016/s0022-510x(02)00265-4
• 发表时间: 2002
• 期刊: Journal of the neurological sciences
• 影响因子: 4.4
• 作者: Toole,JamesF

GRECOS Project (Genotyping Recurrence Risk of Stroke): The Use of Genetics to Predict the Vascular Recurrence After Stroke.

• DOI: 10.1161/strokeaha.116.014322
• 发表时间: 2017-05
• 期刊: Stroke
• 影响因子: 8.3
• 作者: Fernández-Cadenas I;Mendióroz M;Giralt D;Nafria C;Garcia E;Carrera C;Gallego-Fabrega C;Domingues-Montanari S;Delgado P;Ribó M;Castellanos M;Martínez S;Freijo M;Jiménez-Conde J;Rubiera M;Alvarez-Sabín J;Molina CA;Font MA;Grau Olivares M;Palomeras E;Perez de la Ossa N;Martinez-Zabaleta M;Masjuan J;Moniche F;Canovas D;Piñana C;Purroy F;Cocho D;Navas I;Tejero C;Aymerich N;Cullell N;Muiño E;Serena J;Rubio F;Davalos A;Roquer J;Arenillas JF;Martí-Fábregas J;Keene K;Chen WM;Worrall B;Sale M;Arboix A;Krupinski J;Montaner J;GRECOS Study Group
• 通讯作者: GRECOS Study Group

DNA methylation analyses identify an intronic ZDHHC6 locus associated with time to recurrent stroke in the Vitamin Intervention for Stroke Prevention (VISP) clinical trial.

• DOI: 10.1371/journal.pone.0254562
• 发表时间: 2021
• 期刊: PloS one
• 影响因子: 3.7
• 作者: Davis Armstrong NM;Chen WM;Hsu FC;Brewer MS;Cullell N;Fernández-Cadenas I;Williams SR;Sale MM;Worrall BB;Keene KL
• 通讯作者: Keene KL

Genome-wide analysis of blood pressure variability and ischemic stroke.

• DOI: 10.1161/strokeaha.113.002186
• 发表时间: 2013-10
• 期刊: Stroke
• 影响因子: 8.3
• 作者: Yadav S;Cotlarciuc I;Munroe PB;Khan MS;Nalls MA;Bevan S;Cheng YC;Chen WM;Malik R;McCarthy NS;Holliday EG;Speed D;Hasan N;Pucek M;Rinne PE;Sever P;Stanton A;Shields DC;Maguire JM;McEvoy M;Scott RJ;Ferrucci L;Macleod MJ;Attia J;Markus HS;Sale MM;Worrall BB;Mitchell BD;Dichgans M;Sudlow C;Meschia JF;Rothwell PM;Caulfield M;Sharma P;International Stroke Genetics Consortium
• 通讯作者: International Stroke Genetics Consortium

Impact and interaction of low estimated GFR and B vitamin therapy on prognosis among ischemic stroke patients: the Vitamin Intervention for Stroke Prevention (VISP) trial.

低估计 GFR 和 B 族维生素治疗对缺血性中风患者预后的影响和相互作用：预防中风的维生素干预 (VISP) 试验。

• DOI: 10.1053/j.ajkd.2013.02.355
• 发表时间: 2013
• 期刊: American journal of kidney diseases : the official journal of the National Kidney Foundation
• 作者: Lee,Meng;Markovic,Daniela;Ovbiagele,Bruce
• 通讯作者: Ovbiagele,Bruce