Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583161
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Emulation of the Moderate Alcohol and Cardiovascular Health Trial MACH15
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Emulation of the Moderate Alcohol and Cardiovascular Health Trial MACH15
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
To 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
In 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 500000 participants The cardiometabolic effects of moderate drinking vs quitting as originally planned in MACH15 as well as the effects of social and heavybinge drinking on CVD type 2 diabetes other alcohol-related health outcomes and death will be quantified
To 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
In 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 500000 participants The cardiometabolic effects of moderate drinking vs quitting as originally planned in MACH15 as well as the effects of social and heavybinge drinking on CVD type 2 diabetes other alcohol-related health outcomes and death will be quantified
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None