Johns Hopkins University, Baltimore, MD Field Center

约翰霍普金斯大学，巴尔的摩，马里兰州现场中心

• 批准号: 9358709
• 负责人: Mariana Lazo Elizondo
• 金额: $ 27.96万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9358709
• 关键词: Adherence; Adult; Africa; Alcohol Nutrition; Alcohol consumption; Alcohols; Ancillary Study; Area; Baltimore; Behavior Therapy; Behavioral Sciences; Beverages; Biological; Blinded; Body Weight decreased; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Chronic; Chronic Disease; Cities; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collaborations; Coronary heart disease; County; Data; Data Collection; Diabetes Mellitus; Diet; Disease; Documentation; Enrollment; Ensure; Europe; Event; Fatty Liver; Funding; Goals; Guidelines; Health; Health Benefit; Impaired fasting glycaemia; Indigent; Influentials; International; Intervention; Ischemic Stroke; Kidney Diseases; Laboratories; Liver diseases; Measurement; Measures; Medical Records; Methods; Mexico; Monitor; Multi-Institutional Clinical Trial; Multicenter Studies; Myocardial Infarction; National Institute on Alcohol Abuse and Alcoholism; Outcome; Participant; Patient Self-Report; Patients; Phase; Physical activity; Population; Pregnant Women; Prevention; Procedures; Process; Public Health; Quality Control; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Recruitment Activity; Reporting; Research; Research Personnel; Risk; Risk Factors; Safety; Secure; Ships; Site; Sodium; South America; Specimen; Standardization; Testing; Time; United States National Institutes of Health; Universities; aged; alcohol effect; alcohol testing; cardiovascular health; cardiovascular risk factor; clinical epidemiology; design; eligible participant; epidemiology study; experience; flexibility; follow-up; instrument; mortality; novel; quality assurance; randomized trial; response; retention rate; severe mental illness; trial comparing

This goal of this application is to establish a clinical center at Johns Hopkins University in the MACH14 trial. The effects of drinking alcohol within recommended limits on risks of CVD, diabetes, and related diseases are perhaps the most important questions yet to be answered in the fields of alcohol, nutrition, or prevention. Epidemiological studies have consistently found that alcohol intake within recommended limits is associated with lower risk of coronary heart disease, ischemic stroke, and diabetes, yet no long-term randomized trial of alcohol consumption on risk of any chronic disease has yet been performed. In direct response to PAR-16-363 (Multi-Site Randomized Controlled Clinical Trial Research Center on Alcohol's Health Effects), we propose a worldwide, six-year, balanced-design randomized trial, comparing the effects of one standard serving (~14 grams) of alcohol intake daily to abstention on risk of CVD, diabetes, mortality, and related outcomes among 7,800 adults at above-average cardiovascular risk worldwide. To maximize feasibility and reflect actual use most closely, we propose to test alcohol consumption per se to abstention and thus to offer participants flexibility in their choice of beverage, while employing novel and intensive yet efficient methods to monitor safety. The Primary Specific Aim of this trial is to determine the effects of 14 gm of alcohol intake daily compared with abstention on risk of major cardiovascular events or death (myocardial infarction, ischemic stroke, hospitalized angina, need for revascularization, or death) over an average of 6 years of follow-up among 7,800 adults aged ≥50 years with estimated 10-year CVD risk ≥15% or prevalent CVD >6 months prior to enrollment. Secondary Aims will test the effects of alcohol on risks of incident diabetes and major cardiovascular events. Tertiary Aims will test risks of hard cardiovascular events and progression to impaired fasting glucose. Similar to other large randomized trials, we will establish ~16 centers worldwide using a stepped approach, with a 9-month vanguard phase among 7 centers in the US, Europe, Africa, and South America (in this application), followed by a second wave of additional sites to complete enrollment. Participants will be monitored for safety in multiple complementary ways, including brief electronic real-time reporting and validated yearly instruments and laboratory measures. We have brought together highly successful groups in the US and Europe to establish clinical, data, and biospecimen coordinating centers, our field centers include many of the most experienced clinical trialists anywhere, and our group has strong working relationships with NIAAA and other NIH staff necessary to ensure seamless collaboration during a U10-funded cooperative research endeavor. In this application, we propose the first randomized clinical trial of alcohol consumption, aiming to determine whether it increases or decreases the risk of CVD and diabetes among adults at above-average cardiovascular risk worldwide.

该应用程序的这个目标是在Mach14试验中在约翰·霍普金斯大学建立临床中心。 在建议限制内饮酒对CVD，糖尿病和相关疾病风险的影响是 也许在酒精，营养或预防领域要回答的最重要的问题。 流行病学研究一直发现，在推荐限制内酒精摄入量与 患有冠心病，缺血性中风和糖尿病的风险较低，但没有长期随机试验 尚未进行任何慢性病风险的饮酒。直接响应16-363 par （多站点随机对照临床试验研究中心关于酒精的健康影响），我们建议 全球六年平衡设计的随机试验，比较一份标准服务的影响（〜14 克饮酒每天弃用CVD的风险，糖尿病，死亡率和相关结果 全世界的7,800名成年人的心血管风险高于平均水平。最大化可行性并反映实际使用 最接近的是，我们建议测试饮酒本身，以便为参与者提供 他们选择卧室的灵活性，同时采用新颖而密集但有效的方法来监视 安全。该试验的主要目的是确定每天14克酒精摄入的影响 与大型心血管事件或死亡风险的弃权相比（心肌梗塞，缺血性 中风，住院的心绞痛，需要血运重建或死亡），平均随访6年 在7,800名年龄≥50岁的成年人中，估计10年CVD风险≥15％或普遍存在的CVD> 6个月 入学。次要目的将测试酒精对事件糖尿病风险和主要的影响的影响 心血管事件。三级目标将测试硬心血管事件的风险和进展 禁食葡萄糖。与其他大型随机试验类似，我们将在全球范围内建立〜16个中心 在美国，欧洲，非洲和南方的7个中心中，有9个月的先锋 美国（在此应用程序中），然后是第二波其他站点，以完成入学。 参与者将以多种完整的方式监视安全性，包括简短的电子实时 报告和验证的年度工具和实验室措施。我们很高 在美国和欧洲，成功的团体建立临床，数据和生物测量协调中心，我们 现场中心包括许多地方最有经验的临床试验者，我们的小组有很强的 与NIAAA和其他NIH员工的工作关系，以确保在 U10资助的合作研究努力。在此应用中，我们提出了第一个随机临床试验 饮酒，旨在确定它是增加还是降低CVD和糖尿病的风险 在全球高于平均水平的心血管风险的成年人中。