TO-ChERIsH: Trajectory of Cardiovascular Ageing, Its Determinants and Impact on Health

January 10, 2022 updated by: National Heart Centre Singapore

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

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

Observational

Enrollment (Anticipated)

500

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 Contact Backup

Study Locations

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

21 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants are recruited through population based studies (Singhealth IRB 2018/3173).

Description

Inclusion Criteria:

  • >= 21 years old

Exclusion Criteria:

  • Unable to provide written informed consent to participate in the study

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
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

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

Investigators

  • Principal Investigator: Angela Koh, M.D., National Heart Centre 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)

May 13, 2019

Primary Completion (Anticipated)

December 1, 2049

Study Completion (Anticipated)

December 1, 2049

Study Registration Dates

First Submitted

August 2, 2020

First Submitted That Met QC Criteria

August 2, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Actual)

January 12, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2019/2252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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