Evidence map›Paper›PMID 32250171›Full record

ArticleEuropean journal of preventive cardiology2020

The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk.

Donna Spiegelman, Laura C Lovato, Polyna Khudyakov, Trine L Wilkens, Clement A Adebamowo, Sally N Adebamowo, Lawrence J Appel, Joline Wj Beulens, Janelle W Coughlin, Lars Ove Dragsted and 13 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in European journal of preventive cardiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06583161 (Emulation of the Moderate Alcohol and Cardiovascular Health Trial), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06583161 completednot on this map

Emulation of the Moderate Alcohol and Cardiovascular Health Trial (MACH15)

TypeobservationalSponsorHarvard School of Public Health (HSPH)Ran2006 to 2022Enrolled503,325ConditionsMyocardial Infarction, Ischemic Stroke, Angina Pectoris, Coronary RevascularizationArmsModerate drinking, Quitting, Social drinking, Heavy/binge drinking
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors.

Donna SpiegelmanHarvard TH Chan School of Public Health, USA.
Laura C LovatoWake Forest School of Medicine, USA.
Polyna KhudyakovHarvard TH Chan School of Public Health, USA.
Trine L WilkensUniversity of Copenhagen, Denmark.
Clement A AdebamowoDepartment of Epidemiology and Public Health, Greenebaum Comprehensive Cancer Center, University of Maryland, School of Medicine, USA.
Sally N AdebamowoDepartment of Epidemiology and Public Health, Greenebaum Comprehensive Cancer Center, University of Maryland, School of Medicine, USA.
Lawrence J AppelWelch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.
Joline Wj BeulensAmsterdam UMC - location VUmc, Amsterdam Cardiovascular Sciences Research Institute, Netherlands.
Janelle W CoughlinWelch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.
Lars Ove DragstedUniversity of Copenhagen, Denmark.
Howard J EdenbergIndiana University School of Medicine, USA.
Jane N EriksenUniversity of Copenhagen, Denmark.
Ramon EstruchCIBER de Fisiopatología de la Obesidad y la Nutricion (CIBEROBN), Instituto de Salud Carlos III, Spain.
Diederick E GrobbeeJulius Clinical, Netherlands.
Pablo E GulayinJulius Clinical, Netherlands.
Vilma IrazolaJulius Clinical, Netherlands.
John H KrystalYale University School of Medicine, USA.
Mariana LazoWelch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.
Margaret M MurrayYale University School of Medicine, USA.
Eric B RimmHarvard TH Chan School of Public Health, USA.
Ilse C SchrieksDepartment of Internal Medicine, Hospital Clínic, IDIBAPS August Pi i Sunyer Biomedical Research Institute, University of Barcelona, Spain.
Jeff D WilliamsonWake Forest School of Medicine, USA.
Kenneth J MukamalChanning Laboratory, Brigham and Women's Hospital, Harvard Medical School, USA.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Wake Forest Field CenterU10AA025286 · NIAAA · BETH ISRAEL DEACONESS MEDICAL CENTER · PI MUKAMAL, KENNETH JAY · 2016 to 2017
$11.4M
NCATS NIH HHS UL1 TR001863NIAAA NIH HHS U10 AA025286
6 · The paper itself

Abstract

backgroundObservational 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.

aimThe 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.

methodsThis multicenter, parallel-arm randomized trial was designed to compare the effects of one standard serving (∼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.

resultsWe 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 ∼400 additional interested individuals.

conclusionsWe 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.

Indexed as

Alcohol DrinkingAdultAgedCardiovascular DiseasesFeasibility StudiesFemaleFollow-Up StudiesGlobal HealthHumansMaleMetabolic SyndromeMiddle AgedMorbidityMulticenter Studies as TopicRandomized Controlled Trials as TopicRisk Assessmentcardiovascular diseasesdiabetes mellitus type 2ethanolgeriatricRandomized controlled trialresearch design

Identifiers

PMID32250171
PMCPMC7541556

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.