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

May 31, 2016 updated by: National Heart Centre Singapore

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

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

  • Name: Yeo Khung Keong, MBBS
  • Phone Number: 67048963

Study Contact Backup

  • Name: Yuen Yet Lee, Nursing
  • Phone Number: 67042295

Study Locations

  • Singapore
      • Singapore, Singapore, 169609
        • Recruiting
        • National Heart Centre Singapore
        • Contact:
          • Khung Keong Yeo, MBBS
          • Phone Number: 67048963
        • Principal Investigator:
          • Khung Keong Yeo, MBBS

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 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy volunteers age between 21 to 69 years old, Singapore citizens

Description

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

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

  5. More than ongoing use of 2 or more anti-hypertensive agents
  6. Prior history of cancer (excludes pre-cancerous lesions)
  7. Expected life expectancy less than 1 year
  8. Known definite diabetes mellitus or on treatment for diabetes mellitus
  9. Known autoimmune disease or genetic disease
  10. Known endocrine disease on treatment
  11. Psychiatric illness
  12. Asthma or chronic lung disease requiring long term medications or oxygen
  13. Chronic infective disease, including tuberculosis, hepatitis B and C; and HIV
  14. Inability to comply with study protocol
  15. Any other acute or chronic medical or physical condition deemed by the investigator to affect study outcomes

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
First cardiovascular event
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

National Heart Centre Singapore

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2015

Primary Completion (Anticipated)

December 1, 2036

Study Completion (Anticipated)

December 1, 2036

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

May 31, 2016

First Posted (Estimate)

June 6, 2016

Study Record Updates

Last Update Posted (Estimate)

June 6, 2016

Last Update Submitted That Met QC Criteria

May 31, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/2601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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