Journal article
The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk
European journal of preventive cardiology, v 27(18), pp 1967-1982
01 Dec 2020
PMID: 32250171
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Background
Observational studies have documented lower risks of coronary heart disease and diabetes among moderate alcohol consumers relative to abstainers, but only a randomized clinical trial can provide conclusive evidence for or against these associations.
Aim
The purpose of this study was to describe the rationale and design of the Moderate Alcohol and Cardiovascular Health Trial, aimed to assess the cardiometabolic effects of one alcoholic drink daily over an average of six years among adults 50 years or older.
Methods
This multicenter, parallel-arm randomized trial was designed to compare the effects of one standard serving (similar to 11-15 g) daily of a preferred alcoholic beverage to abstention. The trial aimed to enroll 7800 people at high risk of cardiovascular disease. The primary composite endpoint comprised time to the first occurrence of non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalized angina, coronary/carotid revascularization, or total mortality. The trial was designed to provide >80% power to detect a 15% reduction in the risk of the primary outcome. Secondary outcomes included diabetes. Adverse effects of special interest included injuries, congestive heart failure, alcohol use disorders, and cancer.
Results
We describe the design, governance, masking issues, and data handling. In three months of field center activity until termination by the funder, the trial randomized 32 participants, successfully screened another 70, and identified similar to 400 additional interested individuals.
Conclusions
We describe a feasible design for a long-term randomized trial of moderate alcohol consumption. Such a study will provide the highest level of evidence for the effects of moderate alcohol consumption on cardiovascular disease and diabetes, and will directly inform clinical and public health guidelines.
Metrics
Details
- Title
- The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk
- Creators
- Donna Spiegelman - Harvard UniversityLaura C. Lovato - Universitat de BarcelonaPolyna Khudyakov - Harvard UniversityTrine L. Wilkens - University of CopenhagenClement A. Adebamowo - University of MarySally N. Adebamowo - University of MaryLawrence J. Appel - Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.Joline W. J. Beulens - University Medical Center UtrechtJanelle W. Coughlin - Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.Lars Ove Dragsted - University of CopenhagenHoward J. Edenberg - Indiana UniversityJane N. Eriksen - University of CopenhagenRamon Estruch - Instituto de Salud Carlos IIIDiederick E. Grobbee - YuliusPablo E. Gulayin - YuliusVilma Irazola - YuliusJohn H. Krystal - Yale UniversityMariana Lazo - Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.Margaret M. Murray - NIAAA, US Natl Inst Hlth, Bethesda, MD USAEric B. Rimm - Harvard UniversityIlse C. Schrieks - Universitat de BarcelonaJeff D. Williamson - Wake Forest UniversityKenneth J. Mukamal - Brigham and Women's Hospital
- Publication Details
- European journal of preventive cardiology, v 27(18), pp 1967-1982
- Publisher
- Sage
- Number of pages
- 16
- Grant note
- U10AA025286 / U.S. Department of Health and Human Services/National Institutes of Health; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Urban Health Collaborative
- Web of Science ID
- WOS:000524424100001
- Scopus ID
- 2-s2.0-85083169687
- Other Identifier
- 991020550496604721
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InCites Highlights
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- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Cardiac & Cardiovascular Systems