<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04501562</url>
  </required_header>
  <id_info>
    <org_study_id>2019/2252</org_study_id>
    <nct_id>NCT04501562</nct_id>
  </id_info>
  <brief_title>TO-ChERIsH: Trajectory of Cardiovascular Ageing, Its Determinants and Impact on Health</brief_title>
  <official_title>TO-ChERIsH: Trajectory of Cardiovascular Ageing, Its Determinants and Impact on Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Heart Centre Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Heart Centre Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Specific Aim 1: To determine longitudinal changes in CV ageing (changes in CV imaging) over&#xD;
      time.&#xD;
&#xD;
      Hypothesis: There are differences in rates of CV ageing over time.&#xD;
&#xD;
      Specific Aim 2: To study determinants of CV ageing To assess how biological pathways affect&#xD;
      CV ageing by studying the relationships between biological signatures measured in&#xD;
      longitudinal biospecimens are associated with CV ageing.&#xD;
&#xD;
      Hypothesis: Antecedent biological markers are associated with progression of CV ageing.&#xD;
&#xD;
      Specific Aim 3: To determine the impact of CV ageing progression on the development of&#xD;
      clinical CVD and the overall physical, cognitive and functional health of the elderly.&#xD;
&#xD;
      Hypothesis: Those with stable CV imaging phenotypes have lower incidence of clinical CVD and&#xD;
      also better overall health in ageing, compared to those with rapid deterioration (unhealthy&#xD;
      CV ageing).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Singapore, elderly residents aged 65 years and above make up 10.5% of our population and&#xD;
      this is expected to double in 2030 (Singapore Department of Statistics, Ministry of Manpower,&#xD;
      Registry of Birth and Deaths, September 2014). Cardiovascular diseases account for the&#xD;
      majority of disability-adjusted life years by broad cause group, accounting for 20% of&#xD;
      399,675 life years lost due to mortality and ill-health in 2010 (Source: Estimates from the&#xD;
      Singapore Burden of Disease Study 2010).&#xD;
&#xD;
      While chronological ageing is inevitable, a clear understanding is needed as to how ageing&#xD;
      becomes a critical risk component of CVD for some individuals, and the mechanisms through&#xD;
      which ageing results in such a vulnerable phenotype that leads towards clinical CVD.&#xD;
      Following that, clinical tools and clinical guidelines to reduce cardiovascular disease and&#xD;
      other health burdens contributed by ageing may be formulated. Such strategies may potentially&#xD;
      reduce burdens and cost of healthcare provision to the ageing population.&#xD;
&#xD;
      Our proposal will generate data that identifies functional and structural changes in the&#xD;
      cardiovascular system that occur in during ageing. Using a longitudinal design, this research&#xD;
      will provide high quality evidence that distinguishes healthy from unhealthy cardiovascular&#xD;
      ageing, and reveal determinants and impact of CV ageing over time on CVD and associated&#xD;
      health outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 13, 2019</start_date>
  <completion_date type="Anticipated">December 2049</completion_date>
  <primary_completion_date type="Anticipated">December 2049</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To identifies functional and structural changes in the cardiovascular system that occur in during ageing.</measure>
    <time_frame>5 Years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Cardiac Ageing</condition>
  <arm_group>
    <arm_group_label>Subject</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Examinations</intervention_name>
    <description>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.</description>
    <arm_group_label>Subject</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cardiovascular Tests</intervention_name>
    <description>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.</description>
    <arm_group_label>Subject</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bio-specimen collection</intervention_name>
    <description>Bio-specimens collected will include fresh blood, urine and/or stool specimens.</description>
    <arm_group_label>Subject</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical/health outcome collection</intervention_name>
    <description>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.</description>
    <arm_group_label>Subject</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants are recruited through population based studies (Singhealth IRB 2018/3173).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;= 21 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide written informed consent to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angela Koh, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Heart Centre Singapore</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Angela Koh, M.D.</last_name>
    <phone>67042228</phone>
    <email>angela.koh.s.m@singhealth.com.sg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gina Lee, BSc</last_name>
    <email>gina.lee.s.h@nhcs.com.sg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Heart Centre Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>169609</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angela Koh, M.D.</last_name>
      <email>angela.koh.s.m@singhealth.com.sg</email>
    </contact>
    <investigator>
      <last_name>Angela Koh, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>March 7, 2023</last_update_submitted>
  <last_update_submitted_qc>March 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Echocardiogram</keyword>
  <keyword>MRI/MRS</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04501562
org study id: 2019/2252
nct id: NCT04501562
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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.
observational model: Cohort
time perspective: Prospective
measure: To identifies functional and structural changes in the cardiovascular system that occur in during ageing.
time frame: 5 Years
description: 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.
arm group label: Subject
intervention type: Other
intervention name: Examinations
description: 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.
arm group label: Subject
intervention type: Other
intervention name: Cardiovascular Tests
description: 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.
arm group label: Subject
intervention type: Other
intervention name: Bio-specimen collection
description: Bio-specimens collected will include fresh blood, urine and/or stool specimens.
arm group label: Subject
intervention type: Other
intervention name: Clinical/health outcome collection
description: 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.
arm group label: Subject
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Angela Koh, M.D.
role: Principal Investigator
affiliation: National Heart Centre Singapore
last name: Angela Koh, M.D.
phone: 67042228
email: angela.koh.s.m@singhealth.com.sg
last name: Gina Lee, BSc
email: gina.lee.s.h@nhcs.com.sg
facility: 
status: Recruiting
contact: 
investigator: 
country: Singapore
responsible party type: Sponsor
sharing ipd: No