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

NCT06211868 | Recruiting

• 1 other identifier: RESET
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases; Metabolic Syndrome; Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Observational cohort

Randomised cohort

Behavioral: Digital wearable and AI-human symbiotic lifestyle intervention

Interventions

Digital wearable and AI-human symbiotic lifestyle intervention BEHAVIORAL

Digital wearable and AI-human symbiotic lifestyle intervention

Randomised cohort

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

South-East Asian population aged 40-70 years with no prior manifest atherosclerotic cardiovascular disease (ACSVD).

You may qualify if:

• years old
• ASCVD (atherosclerotic cardiovascular disease) score of 5% and higher

You may not qualify if:

• Previous major cardiovascular disease (myocardial infarction, heart failure, ischemic stroke)
• Limited life expectancy
• Other ongoing unstable medical conditions
• Pregnant women

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

NUS

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Hayang Yang, PhD

CONTACT

+6582810448; h.yang@nus.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 18, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: October 15, 2024

Record last verified: 2024-01

Locations

SG (1)