NCT03169530终止不适用
Moderate Alcohol and Cardiovascular Health Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 103
- 试验地点
- 7
- 主要终点
- Cardiovascular Disease or Death
研究概览
简要总结
The Moderate Alcohol and Cardiovascular Health Trial (MACH15) is a multicenter, worldwide, randomized clinical trial of ~15 gm of alcohol daily versus abstention, using a balanced parallel design and single-blind assessment of all outcomes among approximately 7,800 participants aged 50 years and older with advanced cardiovascular risk. Intervention will average 6 years in duration with a common close-out date. Following recruitment and pre-screening, participants will attend a screening visit followed by a two-week abstention washout period, a baseline visit and randomization, and subsequent visits at 3 months, 6 months, 12 months, and then annually until close-out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinical outcome events will be assessed through medical record review by a masked Medical Safety Officer (MSO).
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥50 years at screening
- •Postmenopausal, defined as 12 consecutive months without menstruation
- •Not alcohol naïve, defined by having consumed at least one drink of alcohol in the past five years
- •High risk for the occurrence of a new cardiovascular disease event, defined as having any one of the following:
- •American Heart Association (AHA)/American College of Cardiology (ACC) Risk Score ≥15% within the past 24 months (among those without clinical or subclinical cardiovascular disease [CVD])
- •Clinical CVD (more than 6 months prior to randomization), defined by:
- •Previous myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), carotid endarterectomy (CE), carotid stenting;
- •Peripheral artery disease (PAD) with revascularization;
- •Acute coronary syndrome with or without resting electrocardiogram (ECG) change, ECG changes on a graded exercise test (GXT), or positive cardiac imaging study;
- •Prior stroke documented on brain imaging or with a persistent deficit.
- •Subclinical CVD, confirmed in available medical records:
- •At least a 50% diameter stenosis of a coronary, carotid, or lower extremity artery;
- •Coronary artery calcium score ≥400 Agatston units;
- •Ankle brachial index (ABI) ≤0.90;
- •Left ventricular hypertrophy (LVH) by ECG (based on computer reading), echocardiogram report, or other cardiac imaging procedure report;
- •Abdominal aortic aneurysm (AAA) ≥5 cm with or without repair.
排除标准
- •High alcohol consumption, defined by any one of the following:
- •Alcohol Use Disorders Identification Test (AUDIT) score >5 at screening
- •Drinking, on average, >7 alcoholic beverages/week during the past 6 months
- •Drinking 6 or more alcoholic beverages on one occasion during the past 6 months
- •Yale-Brown Obsessive Compulsive Scale-heavy drinking (Y-BOCS-hd) total score of ≥6 on questions 7, 8, and 10
- •Cardiovascular disease event (MI, revascularization procedure, or stroke) within the 6 months prior to randomization
- •AHA Class III-IV heart failure
- •History of alcohol or substance abuse (medical record confirmed or self-reported history)
- •Other intolerance or allergy to alcohol
- •Dual antiplatelet therapy
- •History of gastric bypass surgery
- •Any serious chronic liver disease (e.g., active hepatitis B and C infections) or liver tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT] and gamma-glutamyl transpeptidase [GGT]) >2 times the upper limit of the normal range using local standards
- •Personal history of any colon or liver cancer
- •Any other cancer with a life expectancy of less than 3 years
- •Diagnosed with breast cancer that required either surgery or removal of breast tissue or chemotherapy
- •Mother or sister ever diagnosed with breast cancer that required either surgery or removal of breast tissue or chemotherapy
- •Estimated glomerular filtration rate (eGFR) <30 ml/min /1.73m2 or end-stage renal disease (ESRD)
- •Ongoing use of any medication for which alcohol consumption is contraindicated
- •A Patient Health Questionnaire (PHQ-9) ≥15 at screening
- •History of any organ transplant
- •Unintentional weight loss >10% in last 6 months
- •Currently participating in another clinical trial (intervention trial) with CVD outcomes. Note: Participant must wait until the completion of his/her activities or the completion of the other trial before being screened for MACH
- •Local restrictions for entry by participants can be more conservative if mandated.
- •Not willing or able to provide a name and contact information for at least one additional contact person other than self
- •Investigator discretion regarding appropriateness of participation or concern about intervention adherence, including:
- •moderate - severe psychiatric illness
- •behavioral concerns regarding likelihood of low adherence to trial protocol
- •a medical condition likely to limit survival to less than 3 years
- •advanced chronic disease, such as dementia, that requires 24-hour care
- •Not willing or able to provide a signed and dated informed consent form
- •Not willing or able to comply with all trial procedures.
结局指标
主要结局
Cardiovascular Disease or Death
时间窗: Every 3 months for up to 90 months or close out, or until date of death
Time from baseline to a composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization for angina, coronary/carotid revascularization, or all-cause mortality.
次要结局
- Cardiovascular Disease(Every 3 months for up to 90 months or close out, or until date of death)
- Diabetes(Every 12 months for 90 months or close out, or until date of first documented occurence)
研究者
Kenneth Mukamal
Principal Investigator
Beth Israel Deaconess Medical Center
研究点 (7)
Loading locations...
相似试验
进行中（未招募）
不适用
Preventing Ischemic Heart Disease With mHealth (Mobile Health), Electronic Decision Support and Community Health WorkersCardiovascular Diseases (CVD)NCT05511701Harvard School of Public Health (HSPH)968
已完成
不适用
Lifestyle Intervention for Cardiovascular Disease Risk Factors Among Female Residents at the National Guard Residential City, Jeddah, Saudi ArabiaCardiovascular DiseasesNCT03532815King Abdullah International Medical Research Center85
Unknown
4 期
Does the Advice to Eat a Mediterranean Diet With Low Carbohydrate Intake, Compared With a Low-fat Diet, Reduce Diabetes and Cardiovascular Disease?Ischemic Heart DiseaseNCT02938832University Hospital, Linkoeping1,200
已完成
3 期
A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT02692716Novo Nordisk A/S3,183
招募中
不适用
Investigating the Combined Effects of Protein, Blueberries, and Exercise on Cardiovascular Health and Frailty in Older Nova ScotiansFrailtyCardiovascular DiseaseNCT06693271Nova Scotia Health Authority240