- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04501562
TO-ChERIsH: Trajectory of Cardiovascular Ageing, Its Determinants and Impact on Health
Specific Aim 1: To determine longitudinal changes in CV ageing (changes in CV imaging) over time.
Hypothesis: There are differences in rates of CV ageing over time.
Specific Aim 2: To study determinants of CV ageing To assess how biological pathways affect CV ageing by studying the relationships between biological signatures measured in longitudinal biospecimens are associated with CV ageing.
Hypothesis: Antecedent biological markers are associated with progression of CV ageing.
Specific Aim 3: To determine the impact of CV ageing progression on the development of clinical CVD and the overall physical, cognitive and functional health of the elderly.
Hypothesis: Those with stable CV imaging phenotypes have lower incidence of clinical CVD and also better overall health in ageing, compared to those with rapid deterioration (unhealthy CV ageing).
Study Overview
Status
Conditions
Detailed Description
In Singapore, elderly residents aged 65 years and above make up 10.5% of our population and this is expected to double in 2030 (Singapore Department of Statistics, Ministry of Manpower, Registry of Birth and Deaths, September 2014). Cardiovascular diseases account for the majority of disability-adjusted life years by broad cause group, accounting for 20% of 399,675 life years lost due to mortality and ill-health in 2010 (Source: Estimates from the Singapore Burden of Disease Study 2010).
While chronological ageing is inevitable, a clear understanding is needed as to how ageing becomes a critical risk component of CVD for some individuals, and the mechanisms through which ageing results in such a vulnerable phenotype that leads towards clinical CVD. Following that, clinical tools and clinical guidelines to reduce cardiovascular disease and other health burdens contributed by ageing may be formulated. Such strategies may potentially reduce burdens and cost of healthcare provision to the ageing population.
Our proposal will generate data that identifies functional and structural changes in the cardiovascular system that occur in during ageing. Using a longitudinal design, this research will provide high quality evidence that distinguishes healthy from unhealthy cardiovascular ageing, and reveal determinants and impact of CV ageing over time on CVD and associated health outcomes.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Angela Koh, M.D.
- Phone Number: 67042228
- Email: angela.koh.s.m@singhealth.com.sg
Study Contact Backup
- Name: Gina Lee, BSc
- Email: gina.lee.s.h@nhcs.com.sg
Study Locations
-
-
-
Singapore, Singapore, 169609
- Recruiting
- National Heart Centre Singapore
-
Contact:
- Angela Koh, M.D.
- Email: angela.koh.s.m@singhealth.com.sg
-
Principal Investigator:
- Angela Koh, M.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- >= 21 years old
Exclusion Criteria:
- Unable to provide written informed consent to participate in the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subject
|
Participants will undergo focused examinations that include measurement of height, weight, waist circumference, body composition analysis, baseline data collection and blood pressure examinations.
Resting electrocardiography will be performed to ascertain sinus rhythm.
Specific quantitative cardiac ageing-related outcome parameters will be examined by multimodal techniques including two-dimensional transthoracic echocardiogram, and/or non-contrast magnetic resonance imaging/magnetic resonance spectroscopy.
Bio-specimens collected will include fresh blood, urine and/or stool specimens.
Health status will be tracked by telephone follow-up and/or matching at national disease registries at periodic intervals within one to five years, up to three decades.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To identifies functional and structural changes in the cardiovascular system that occur in during ageing.
Time Frame: 5 Years
|
Health status will be tracked by telephone follow-up and/or matching at national disease registries at periodic intervals within one to five years, up to three decades.
|
5 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Angela Koh, M.D., National Heart Centre Singapore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019/2252
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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