CREST-2 Statistical and Data Coordinating Center - SDCC

CREST-2 统计和数据协调中心 - SDCC

基本信息

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
项目类别：
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

项目摘要

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、长期目标是促进因颈动脉粥样硬化而面临中风风险的患者的中风一级预防。美国有百分之一到二的成年人患有超过 50 度的无症状颈动脉粥样硬化狭窄。 % 颈动脉狭窄通常通过颈动脉内膜切除术或支架置入术来治疗。美国每年进行 40,000 例颈动脉支架置入手术，其中高达 90% 的手术对象是无症状患者。 20 世纪 80 年代和 90 年代开始评估血运重建术疗效的试验结果显示，血运重建术的疗效现在受到质疑。由于预防动脉粥样硬化和动脉粥样硬化的药物治疗的改进以及动脉内膜切除术和颈动脉血运重建的同时改善为了解决如何最好地治疗颈动脉分叉狭窄患者以预防中风的问题，我们目前正在完成 CREST-2 试验的第一个资助周期，CREST-2 是两项平行随机、多中心试验。主要目的：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，2) 比较 IMM 与颈动脉内膜切除术加 IMM 的有效性。颈动脉支架置入术加 IMM（n=1240）的主要终点是随机分组后 44 天内的任何卒中或死亡（围手术期风险）加上长达 4 年随访的同侧卒中的复合终点。通过集中、标准化的计算机辅助电话访谈定期评估 IMM 涉及血管危险因素的集中管理，包括高血压、糖尿病、吸烟和高脂血症的主要危险因素治疗目标是收缩压<130 mmHg 和低密度脂蛋白(LDL) 胆固醇水平<70 mg/dL。初步数据显示，IMM 还包括电话提供的定期生活方式指导。截至 2020 年 10 月 26 日，IMM 显着改善了各治疗组的血管危险因素，总共改善了 70% (1734/2480)。所需患者已在美国、加拿大和西班牙进行了随机分配，所有手术均由经过严格认证的外科医生和介入医师进行，并且血运重建手术均在设计假设范围内成功实施。 CREST-2 支持一项名为 CREST-H (NCT03121209) 的配套辅助研究，该研究测试血运重建对半球灌注不足患者的认知影响。我们请求支持以完成招募、完成队列随访（招募最后一名患者后 2 年）并报告研究结果。