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SingHEART: Effects of Physical Activity, Ambulatory Blood Pressure and Calcium Score on Cardiovascular Health in Normal People

Sponsor
National Heart Centre Singapore (Other)
Overall Status
Recruiting
CT.gov ID
NCT02791152
Collaborator
(none)
1,000
Enrollment
1
Location
254
Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective cohort of relatively healthy individuals, using comprehensive clinical information, advanced imaging (including cardiac MRI), cardiovascular exercise physiology, metabolomics and genetic analysis. These findings will be correlated with adverse clinical outcomes including death, stroke and myocardial infarction. In selected cases, follow-up imaging and biomarker samples will also be obtained. These studies will enable us to begin to address a critical gap in our knowledge as to how best to interpret the very large amount of cardiovascular tests done in Singapore and how to better to predict outcomes and manage healthcare costs in our local populations

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    SingHEART sub-study will collect the following data types or perform the following investigations:

    1. Demographic and clinical characteristics data.

    2. Basic blood investigations. Basic blood investigations include: FBC, CRP, renal panel, random glucose, LFT, fasting lipids, ESR, CRP,

    3. Perform a single baseline cardiac MRI (already consented and obtained as part of the primary study).

    4. ECG

    5. Calcium score

    6. Biobanking (whole blood, plasma and serum, already performed as part of the primary study)

    7. Exercise and physical activity tracker over two 1-week periods

    8. Ambulatory BP monitoring over two 24-48H periods

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    SingHEART: Effects of Physical Activity, Ambulatory Blood Pressure and Calcium Score on Cardiovascular Health in Normal People
    Study Start Date :
    Oct 1, 2015
    Anticipated Primary Completion Date :
    Dec 1, 2036
    Anticipated Study Completion Date :
    Dec 1, 2036

    Outcome Measures

    Primary Outcome Measures

    1. First cardiovascular event [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 69 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Men and women age 21-69 years
    Exclusion Criteria:

    1. Previous myocardial infarction (MI). This will include ST-elevation MI (STEMI) and non-ST-elevation MI (NSTEMI)

    2. Known coronary artery disease - prior coronary revascularization

    3. Known documented peripheral arterial disease

    4. Previous stroke

    1. Stroke is defined as new focal neurological deficit persisting more than 24hours21.

    1. More than ongoing use of 2 or more anti-hypertensive agents

    2. Prior history of cancer (excludes pre-cancerous lesions)

    3. Expected life expectancy less than 1 year

    4. Known definite diabetes mellitus or on treatment for diabetes mellitus

    5. Known autoimmune disease or genetic disease

    6. Known endocrine disease on treatment

    7. Psychiatric illness

    8. Asthma or chronic lung disease requiring long term medications or oxygen

    9. Chronic infective disease, including tuberculosis, hepatitis B and C; and HIV

    10. Inability to comply with study protocol

    11. Any other acute or chronic medical or physical condition deemed by the investigator to affect study outcomes

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Heart Centre Singapore Singapore Singapore 169609

    Sponsors and Collaborators

    • National Heart Centre Singapore

    Investigators

    • Principal Investigator: Yeo Khung Keong, MBBS, National Heart Centre Singapore

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Heart Centre Singapore
    ClinicalTrials.gov Identifier:
    NCT02791152
    Other Study ID Numbers:
    • 2015/2601
    First Posted:
    Jun 6, 2016
    Last Update Posted:
    Jun 6, 2016
    Last Verified:
    Sep 1, 2015
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Jun 6, 2016