CREST-2 Statistical and Data Coordinating Center - SDCC

CREST-2 统计和数据协调中心 - SDCC

• 批准号: 10298040
• 负责人: George Howard
• 金额: $ 158.73万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-03-15 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10298040
• 关键词: Abbreviations; Address; Adult; Affect; Age; Ancillary Study; Applications Grants; Atherosclerosis; Blinded; Blood Pressure; COVID-19; COVID-19 pandemic; Canada; Carotid Arteries; Carotid Atherosclerotic Disease; Carotid Endarterectomy; Carotid Stenosis; Carotid stent; Cessation of life; Clinic; Clinical Trials; Clinical Trials Data Monitoring Committees; Companions; Computer Assisted; Credentialing; Data; Data Coordinating Center; Devices; Diabetes Mellitus; Doppler Ultrasound; Endarterectomy; Enrollment; Ensure; Event; Funding; Goals; Hyperlipidemia; Hypertension; Informed Consent; Investigation; Ipsilateral; Knowledge; LDL Cholesterol Lipoproteins; Life Style; Lipoproteins; Maryland; Medical; Medical Records; Modernization; Monitor; Multicenter Trials; Operative Surgical Procedures; Outcome; Outcome Study; Patient Recruitments; Patients; Periodicity; Primary Prevention; Procedures; Proprotein Convertases; Radial; Randomized; Randomized Clinical Trials; Recommendation; Reporting; Research Design; Research Personnel; Risk; Risk Factors; Risk Reduction; Serine Protease; Severities; Site; Spain; Standardization; Statistical Data Interpretation; Stenosis; Stents; Stroke; Stroke prevention; Subtilisins; Surgeon; Symptoms; Telephone; Telephone Interviews; United States; Universities; Withdrawal; adjudicate; atherothrombosis; base; cardiovascular risk factor; cigarette smoking; clinical application; cognitive change; cognitive function; cognitive testing; cohort; compare effectiveness; data management; design; experience; follow up assessment; follow-up; hypoperfusion; improved; inhibitor/antagonist; meetings; operation; prevent; primary endpoint; primary outcome; randomized trial; recruit; safe patient; secondary endpoint; secondary outcome; sex; statistical center; stroke event; stroke risk; success; therapeutic target; treatment arm; treatment group; trial comparing; vascular risk factor

The broad, long-term objective of this application is to advance primary prevention of stroke in patients at risk for stroke due to atherosclerosis of the carotid artery. One to two percent of adults in the U.S. have asymptomatic atherosclerotic stenosis of the carotid artery exceeding 50% luminal narrowing. Carotid stenosis is often managed either by endarterectomy or stenting. About 100,000 carotid endarterectomies and 40,000 carotid stenting procedures are done each year in the US. Up to 90% of these procedures are done on asymptomatic patients. The findings of trials assessing the efficacy of revascularization begun in the 1980’s and 1990’s that showed efficacy of revascularization are now in question because of improvements in medical therapy to prevent atherosclerosis and atherothrombosis and concurrent improvements in revascularization by endarterectomy and by carotid stenting. To address the question of how best to treat patients with ≥70% carotid bifurcation stenosis to prevent stroke, we are currently completing the first funding cycle for the CREST-2 trials. CREST-2 is a pair of parallel randomized, multicenter trials with the primary aims: 1) to compare the effectiveness of intensive medical management (IMM) vs. carotid endarterectomy plus IMM (n=1240), and 2) to compare the effectiveness of IMM vs. carotid stenting plus IMM (n=1240). The primary endpoint is a composite of any stroke or death within 44 days of randomization (periprocedural risk) plus ipsilateral stroke up to 4 years of follow-up. An important secondary endpoint is cognitive function, assessed periodically and by a centralized, standardized computer- aided telephone interview. Endpoints are assessed in a manner blinded to treatment assignment. IMM involves central management of vascular risk factors, including hypertension, diabetes mellitus, cigarette smoking and hyperlipidemia. Primary risk factor therapeutic targets are systolic blood pressure <130 mmHg and a low- density lipoprotein (LDL) cholesterol level of <70 mg/dL. IMM also includes telephone-delivered periodic lifestyle coaching. Preliminary data show that the IMM has significantly favorably improved vascular risk factors across treatment arms. As of October 26, 2020, a total of 70% (1734/2480) of the required patients have been randomized across the US, Canada, and Spain. All procedures are performed only by rigorously credentialed surgeons and interventionists. IMM and revascularization procedures are being successfully delivered. Cross- overs and withdrawal from the study are within design assumptions, and the quality of the data is high. CREST-2 supports a companion ancillary study known as CREST-H (NCT03121209) that tests the cognitive implications of revascularization in patients with hemispheric hypoperfusion. We are requesting support to complete recruitment, complete follow-up of the cohort (2-years after recruitment of last patient), and report study results.

该应用的广泛，长期目标是提高由于颈动脉动脉粥样硬化而导致的中风风险的患者中风的一级预防。在美国，成年人中有一到2％的颈动脉不对称动脉粥样硬化狭窄超过50％的腔内狭窄。颈动脉狭窄通常是通过内膜切除术或支架来治疗的。在美国，每年大约有100,000个颈动脉内膜切除术和40,000个颈动脉支架置换程序。这些手术中最多有90％是对不对称患者进行的。由于改善医疗疗法的改善，可预防动脉粥样硬化和动脉粥样硬化术的改善，并通过持续切除术和颈动脉膨胀，评估了1980年代和1990年代从1980年代和1990年代开始表现出血运重建效率的试验结果的试验结果。为了解决如何最好地治疗颈动脉分叉狭窄以防止中风的患者的问题，我们目前正在完成CREST-2试验的第一个资金周期。 CREST-2是一对平行的随机多中心试验，主要目的是：1）比较强化医疗管理（IMM）与颈动脉内膜切除术加IMM（n = 1240）的有效性，以比较IMM与Carotid架构的有效性与Carotid Stenting Plus Plus IMM（N = 1240）。主要终点是在随机化的44天内进行任何中风或死亡的综合（围骨围栏风险）加上高达4年随访的同侧中风。一个重要的次要终点是认知功能，定期通过集中的，标准化的计算机辅助电话采访进行评估。终点以对治疗分配的视而不见的方式进行评估。 IMM涉及血管危险因素的中央管理，包括高血压，糖尿病，吸烟和高脂血症。主要危险因素治疗靶点是收缩压<130 mmHg和低密度脂蛋白（LDL）胆固醇水平<70 mg/dL。 IMM还包括电话传递的定期生活方式教练。初步数据表明，IMM可以显着改善整个治疗组的血管危险因素。截至2020年10月26日，在美国，加拿大和西班牙，总共有70％（1734/2480）被随机分配。所有程序仅由严格的凭证外科医生和干预主义者执行。 IMM和血运重建程序正在成功提供。跨研究和退出研究属于设计假设，数据的质量很高。 CREST-2支持一项称为CREST-H（NCT03121209）的辅助辅助研究，该研究测试了半球下灌注不足患者血运重建的认知意义。我们要求提供支持，以完成招聘，完成队列的完整随访（在最后一名患者招募后两年），并报告研究结果。