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: 9197822
• 负责人: Mariana Lazo Elizondo
• 金额: $ 49.88万
• 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/9197822
• 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 Cooperative Group; Collaborations; Coronary heart disease; County; Data; Data Collection; Diabetes Mellitus; Diet; Disease; Documentation; Electronics; Enrollment; Ensure; Epidemiologic Studies; Equilibrium; 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; Reporting; Research; Research Personnel; Risk; Risk Factors; Safety; Secure; Shipping; Ships; Site; Sodium; South America; Specimen; Testing; Time; United States National Institutes of Health; Universities; Work; aged; alcohol effect; cardiovascular health; cardiovascular risk factor; clinical epidemiology; design; eligible participant; 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.

该应用程序的目标是在约翰·霍普金斯大学建立 MACH14 试验的临床中心。 在建议限度内饮酒对心血管疾病、糖尿病和相关疾病风险的影响是 也许在酒精、营养或预防领域尚未解答的最重要的问题。 流行病学研究一致发现，建议限度内的酒精摄入量与 冠心病、缺血性中风和糖尿病的风险较低，但尚无长期随机试验 饮酒对任何慢性疾病风险的影响尚未针对 PAR-16-363 进行直接反应。 （酒精对健康影响的多中心随机对照临床试验研究中心），我们提出了 全球范围内为期六年的平衡设计随机试验，比较一份标准份量的效果（~14 克）每日饮酒量到戒酒对心血管疾病、糖尿病、死亡率和相关结果的风险 全球 7,800 名心血管风险高于平均水平的成年人 最大限度地提高可行性并反映实际使用情况。 最接近的是，我们建议测试饮酒本身是否戒酒，从而提供 灵活选择饮料，同时采用新颖、密集且有效的方法进行监控 该试验的主要具体目标是确定每天摄入 14 克酒精的影响。 与弃权相比，重大心血管事件或死亡（心肌梗塞、缺血性心脏病）的风险 平均 6 年随访期间（中风、住院心绞痛、需要血运重建或死亡） 7,800 名年龄 ≥ 50 岁的成年人中，估计 10 年 CVD 风险≥ 15% 或 CVD 患病率 > 6 个月 次要目标将测试酒精对糖尿病和重大疾病风险的影响。 第三目标将测试严重心血管事件和进展为受损的风险。 与其他大型随机试验类似，我们将在全球范围内建立约 16 个中心，使用 阶梯式方法，在美国、欧洲、非洲和南部非洲的 7 个中心中进行为期 9 个月的先锋阶段 美国（在此申请中），随后第二波额外站点完成注册。 将以多种补充方式监控参与者的安全，包括简短的电子实时监控 我们高度汇集了年度仪器和实验室测量报告和验证。 美国和欧洲的成功团体建立了临床、数据和生物样本协调中心，我们的 现场中心包括许多最有经验的临床试验人员，我们的团队拥有强大的 与 NIAAA 和其他 NIH 工作人员建立必要的工作关系，以确保在 U10 资助的合作研究工作在此申请中，我们提出了第一个随机临床试验。 饮酒，旨在确定饮酒是否会增加或降低患心血管疾病和糖尿病的风险 全球心血管风险高于平均水平的成年人。