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NCT06211868 Clinical Trial

Redirecting Immune, Lipid and Metabolic Drivers of Early Cardiovascular Disease: The RESET Cohort Study

Cardiovascular Diseases Clinical Trial

— RESET  

Official title:
Redirecting Immune, Lipid and Metabolic Drivers of Early Cardiovascular Disease: The RESET Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06211868
Other study ID # RESET
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2024
Est. completion date February 1, 2030

Study information
Verified date January 2024
Source National University Hospital, Singapore
Contact Hayang Yang, PhD
Phone +6582810448
Email h.yang@nus.edu.sg
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Project RESET is a Singapore National Medical Research Council Large Collaborative Grant funded program that brings together a nationwide community of cardiovascular, metabolic, and digital health researchers, as well as clinicians across primary and tertiary care to study the immune, lipid and metabolic drivers of early cardiovascular disease. RESET incorporates a nested randomised controlled trials (RCT) to test the use of a combined digital wearable and AI-human symbiotic lifestyle intervention to halt or reverse the progression of early disease.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 3000
Est. completion date February 1, 2030
Est. primary completion date February 1, 2029
Accepts healthy volunteers
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria: - 40-70 years old - ASCVD (atherosclerotic cardiovascular disease) score of 5% and higher Exclusion Criteria: - Previous major cardiovascular disease (myocardial infarction, heart failure, ischemic stroke) - Limited life expectancy - Other ongoing unstable medical conditions - Pregnant women

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Digital wearable and AI-human symbiotic lifestyle intervention
Digital wearable and AI-human symbiotic lifestyle intervention

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National University Hospital, Singapore National University of Singapore

Outcome
Type Measure Description Time frame Safety issue
Primary Major adverse cardiovascular event Composite of cardiac death, non-fatal myocardial infarction, resuscitated cardiac arrest, non-fatal ischemic stroke, congestive heart failure, coronary revascularization 5 years
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