Cardiovascular DiseasesRESETNCT06211868
Redirecting Immune, Lipid and Metabolic Drivers of Early Cardiovascular Disease: The RESET Cohort Study
An observational study of Cardiovascular Diseases and Metabolic Syndrome, run by National University Hospital, Singapore at 1 site in Singapore.
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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Cardiovascular Diseases, Metabolic Syndrome, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Digital wearable and AI-human symbiotic lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,000 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2024to 1 Sep 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Adult, Older adult
Study population: South-East Asian population aged 40-70 years with no prior manifest atherosclerotic cardiovascular disease (ACSVD).
Who may be able to join
- 40-70 years old
- ASCVD (atherosclerotic cardiovascular disease) score of 5% and higher
Who cannot join
- Previous major cardiovascular disease (myocardial infarction, heart failure, ischemic stroke)
- Limited life expectancy
- Other ongoing unstable medical conditions
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- Digital wearable and AI-human symbiotic lifestyle intervention
- Medical subject headings
- Cardiovascular Diseases, Metabolic Syndrome, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital wearable and AI-human symbiotic lifestyle interventionBehavioural
Digital wearable and AI-human symbiotic lifestyle intervention
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort | Not described | |
| Randomised cohort | Not described Receives: Behavioral: Digital wearable and AI-human symbiotic lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular event
Composite of cardiac death, non-fatal myocardial infarction, resuscitated cardiac arrest, non-fatal ischemic stroke, congestive heart failure, coronary revascularization
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Mar 2024
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211868
- Sponsor's protocol ID
- RESET
- Acronym
- RESET
- Status last verified
- Jan 2024
- First submitted
- 6 Dec 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redirecting Immune, Lipid and Metabolic Drivers of Early Cardiovascular Disease: The RESET Cohort Study
- ClinicalTrials.gov ID
- NCT06211868
- Acronym / sponsor ID
- RESET / RESET
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational cohort | – | – |
| Randomised cohort | – | Behavioral: Digital wearable and AI-human symbiotic lifestyle intervention |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- South-East Asian population aged 40-70 years with no prior manifest atherosclerotic cardiovascular disease (ACSVD).
Key inclusion criteria (2 listed)
- 40-70 years old
- ASCVD (atherosclerotic cardiovascular disease) score of 5% and higher
Key exclusion criteria (4 listed)
- Previous major cardiovascular disease (myocardial infarction, heart failure, ischemic stroke)
- Limited life expectancy
- Other ongoing unstable medical conditions
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital wearable and AI-human symbiotic lifestyle interventionDigital wearable and AI-human symbiotic lifestyle intervention | Behavioural | Randomised cohort |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Metabolic Syndrome, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayang Yang, PhD (+6582810448, h.yang@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular event (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.