Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-27 @ 10:30 AM
Study NCT ID:
NCT06583161
Status:
COMPLETED
Last Update Posted:
2024-09-03
First Post:
2024-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emulation of the Moderate Alcohol and Cardiovascular Health Trial (MACH15)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 503325}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2024-08-28', 'studyFirstSubmitQcDate': '2024-08-30', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hard cardiovascular disease or death', 'timeFrame': 'From date of baseline measurement until the date of first hard cardiovascular disease or death documented in hospital or death registry data, admin. censoring, loss to follow-up, or death from other causes, whichever came first, assessed up to 200 months', 'description': 'Composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, and cardiovascular death'}, {'measure': 'Cardiovascular death', 'timeFrame': 'From date of baseline measurement until the date of cardiovascular death documented in death registry data, administrative censoring, loss to follow-up, or death from other causes, whichever came first, assessed up to 200 months', 'description': 'Cardiovascular death'}, {'measure': 'Non-fatal myocardial infarction', 'timeFrame': 'From date of baseline measurement until the date of first non-fatal myocardial infarction documented in hospital data, administrative censoring, loss to follow-up, or death, whichever came first, assessed up to 200 months', 'description': 'First occurrence of a non-fatal myocardial infarction'}, {'measure': 'Non-fatal ischemic stroke', 'timeFrame': 'From date of baseline measurement until the date of first non-fatal ischemic stroke documented in hospital data, administrative censoring, loss to follow-up, or death, whichever came first, assessed up to 200 months', 'description': 'First occurrence of a non-fatal ischemic stroke'}, {'measure': 'Hospitalization for angina', 'timeFrame': 'From date of baseline measurement until the date of first hospitalization for angina documented in hospital data, administrative censoring, loss to follow-up, or death, whichever came first, assessed up to 200 months', 'description': 'First hospitalization for angina'}, {'measure': 'Coronary/carotid revascularization', 'timeFrame': 'From date of baseline measurement until the date of first coronary/carotid revascularization documented in hospital data, administrative censoring, loss to follow-up, or death, whichever came first, assessed up to 200 months', 'description': 'First coronary/carotid revascularization'}, {'measure': 'All-cause mortality', 'timeFrame': 'From date of baseline measurement until the date of death documented in death registry data, administrative censoring, or loss to follow-up, whichever came first, assessed up to 200 months', 'description': 'Death'}], 'primaryOutcomes': [{'measure': 'Cardiovascular disease or death', 'timeFrame': 'From date of baseline measurement until the date of first cardiovascular disease or death documented in hospital or death registry data, administrative censoring, or loss to follow-up, whichever came first, assessed up to 200 months', 'description': 'Composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization for angina, coronary/carotid revascularization, and all-cause mortality'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular disease', 'timeFrame': 'From date of baseline measurement until the date of first cardiovascular disease documented in hospital or death registry data, administrative censoring, loss to follow-up, or death from other causes, whichever came first, assessed up to 200 months', 'description': 'Composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization for angina, coronary/carotid revascularization, and cardiovascular death'}, {'measure': 'Type 2 diabetes', 'timeFrame': 'From date of baseline measurement until the date of first type 2 diabetes documented in hospital or death registry data, administrative censoring, loss to follow-up, or death from other causes, whichever came first, assessed up to 200 months', 'description': 'Progression among normoglycemic and pre-diabetes individuals to type 2 diabetes'}, {'measure': 'Alcohol-related disease or death', 'timeFrame': 'From date of baseline measurement until the date of first alcohol-related disease or death documented in hospital, cancer, or death registry data, administrative censoring, or loss to follow-up, whichever came first, assessed up to 200 months', 'description': 'Composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, heart failure, atrial fibrillation, cancer (except non-melanoma skin cancer), dementia, depression, infection with hospitalization, injury with hospitalization, liver cirrhosis, type 2 diabetes, and all-cause mortality'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction', 'Ischemic Stroke', 'Angina Pectoris', 'Coronary Revascularization', 'All-cause Mortality', 'Cardiovascular Death', 'Type 2 Diabetes', 'Heart Failure', 'Atrial Fibrillation', 'Cancer', 'Dementia', 'Depression', 'Infections', 'Injuries', 'Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '32250171', 'type': 'BACKGROUND', 'citation': 'Spiegelman D, Lovato LC, Khudyakov P, Wilkens TL, Adebamowo CA, Adebamowo SN, Appel LJ, Beulens JW, Coughlin JW, Dragsted LO, Edenberg HJ, Eriksen JN, Estruch R, Grobbee DE, Gulayin PE, Irazola V, Krystal JH, Lazo M, Murray MM, Rimm EB, Schrieks IC, Williamson JD, Mukamal KJ. The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk. Eur J Prev Cardiol. 2020 Dec;27(18):1967-1982. doi: 10.1177/2047487320912376. Epub 2020 Apr 6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess how long-term alcohol consumption influences health risks by emulating the Moderate Alcohol and Cardiovascular Health Trial (MACH15). In the first step, the protocol of the emulation of MACH15, including eligibility criteria, alcohol regimens and assignment, follow-up, endpoints, causal contrasts of interest, and statistical analysis was specified. In the second step, the investigators will emulate an adapted version of MACH15 following the specified protocol using data from the UK Biobank.', 'detailedDescription': 'Observational data suggests that alcohol consumption lowers the risk of cardiovascular disease (CVD) compared to no consumption. Whether this relationship is truly causal remains uncertain because of the inherent limitations of observational studies, including unmeasured confounding and reverse causation. Mendelian randomization studies using genes as instrumental variables for alcohol are partially protected from these biases and have found no or harmful associations between alcohol consumption and CVD.\n\nTo date, there has only been one long-term randomized controlled trial to investigate the cardiovascular effects of alcohol consumption: the Moderate Alcohol and Cardiovascular Health Trial (MACH15; NCT Number: NCT03169530). It was, however, terminated shortly after initiation. An alternative to a real randomized trial like MACH15, which must first be completed and is subject to strict eligibility criteria to ensure safety, is to use observational data to emulate a (hypothetical) pragmatic randomized trial.\n\nIn this study, the investigators will emulate an adapted version of MACH15 using observational data from the UK Biobank, a large prospective cohort study of over 500,000 participants. The cardiometabolic effects of moderate drinking vs quitting, as originally planned in MACH15, as well as the effects of social and heavy/binge drinking on CVD, type 2 diabetes, other alcohol-related health outcomes, and death will be quantified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All people aged 40-69 years who were registered with the National Health Service and lived within 25 miles of one of the 22 study assessment centers in England, Wales, and Scotland were invited to participate. Overall, about 9.2 million invitations were mailed in order to recruit 503,325 participants (i.e. a response rate of 5.47%)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* 40-69 years old at enrollment\n* Currently drinking\n\nExclusion criteria:\n\n* Within the six months prior to baseline, cardiovascular disease event (myocardial infarction, revascularization procedure, or stroke)\n* Hospitalization due to heart failure\n* History of any of the following alcohol-related conditions, confirmed by a hospital record: alcoholic cardiomyopathy, alcoholic gastritis, alcoholic liver disease, degeneration of the nervous system due to alcohol, alcoholic myopathy, alcoholic polyneuropathy, alcohol-induced acute or chronic pancreatitis, alcohol use disorder; or self-reported history of alcoholic liver disease or alcohol use disorder\n* Dual antiplatelet therapy or coumarin anticoagulants\n* Serious chronic liver disease (active hepatitis B or C infection) in the past 6 months before baseline\n* Personal history of any colon or liver cancer\n* Personal history of breast cancer\n* Diagnosis of dementia\n* Not willing or able to provide a signed and dated informed consent form\n* Reduced alcohol compared to 10 years ago due to illness, ill health, or doctor's advice\n* Self-reported poor health"}, 'identificationModule': {'nctId': 'NCT06583161', 'briefTitle': 'Emulation of the Moderate Alcohol and Cardiovascular Health Trial (MACH15)', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Emulation of the Moderate Alcohol and Cardiovascular Health Trial (MACH15)', 'orgStudyIdInfo': {'id': 'IRB23-1533'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Moderate drinkers', 'description': 'Participants who report drinking up to 16 grams of alcohol daily or almost daily on a repeated assessment center visit, or who report drinking 8-16 grams of alcohol 4 or more times per week on the web-based mental health questionnaire.', 'interventionNames': ['Behavioral: Moderate drinking']}, {'label': 'Quitters', 'description': 'Participants who report not drinking alcohol on a repeated assessment center visit or in the web-based mental health questionnaire.', 'interventionNames': ['Behavioral: Quitting']}, {'label': 'Social drinkers', 'description': 'Participants who report drinking up to 16 grams of alcohol 1-2 days per week or drinking 1-3 times per month or only on special occasions on a repeated assessment center visit, or who report drinking 8-16 grams of alcohol 2-3 times per week or drinking 4 times per month or less in the web-based mental health questionnaire.', 'interventionNames': ['Behavioral: Social drinking']}, {'label': 'Heavy/binge drinkers', 'description': 'Participants who report drinking more than 16 grams of alcohol daily or almost daily or drinking more than 40 grams of alcohol 1-2 days per week on a repeated assessment center visit, or who report drinking 24 grams of alcohol or more 4 or more times per week or 40 grams of alcohol or more 2-3 times per week on the web-based mental health questionnaire.', 'interventionNames': ['Behavioral: Heavy/binge drinking']}], 'interventions': [{'name': 'Moderate drinking', 'type': 'BEHAVIORAL', 'description': 'Drink up to 16 grams of alcohol daily or almost daily \\[repeated assessment center visit\\] or 8-16 grams of alcohol 4 or more times per week \\[web-based mental health questionnaire\\]', 'armGroupLabels': ['Moderate drinkers']}, {'name': 'Quitting', 'type': 'BEHAVIORAL', 'description': 'No alcohol consumption', 'armGroupLabels': ['Quitters']}, {'name': 'Social drinking', 'type': 'BEHAVIORAL', 'description': 'Drink up to 16 grams of alcohol 1-2 days per week or drink 1-3 times per month or only on special occasions \\[repeated assessment center visit\\], or drink 8-16 grams of alcohol 2-3 times per week or drink 4 times per month or less \\[web-based mental health questionnaire\\]', 'armGroupLabels': ['Social drinkers']}, {'name': 'Heavy/binge drinking', 'type': 'BEHAVIORAL', 'description': 'Drink more than 16 grams of alcohol daily or almost daily or more than 40 grams of alcohol 1-2 days per week \\[repeated assessment center visit\\], or 24 grams of alcohol or more 4 or more times per week or 40 grams of alcohol or more 2-3 times per week \\[web-based mental health questionnaire\\]', 'armGroupLabels': ['Heavy/binge drinkers']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Access to the UK Biobank data can be requested via the official website https://www.ukbiobank.ac.uk.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Goodarz Danaei', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}