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

October 10, 2024 updated by: National University Hospital, Singapore
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • NUS
        • Contact:
          • Hayang Yang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational cohort
Randomised cohort
Behavioral: Digital wearable and AI-human symbiotic lifestyle intervention
Digital wearable and AI-human symbiotic lifestyle intervention

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

National University of Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

December 6, 2023

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESET (Alias Study Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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