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NCT Number: NCT02791152

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

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Key information

Age range

21 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Heart Centre Singapore

Singapore, 169609

Location status: Recruiting

Location contact

Khung Keong Yeo, MBBS

CONTACT

67048963

Khung Keong Yeo, MBBS

PRINCIPAL_INVESTIGATOR

About this study

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

  • Demographic and clinical characteristics data.
  • Basic blood investigations. Basic blood investigations include: FBC, CRP, renal panel, random glucose, LFT, fasting lipids, ESR, CRP,
  • Perform a single baseline cardiac MRI (already consented and obtained as part of the primary study).
  • ECG
  • Calcium score
  • Biobanking (whole blood, plasma and serum, already performed as part of the primary study)
  • Exercise and physical activity tracker over two 1-week periods
  • Ambulatory BP monitoring over two 24-48H periods

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women age 21-69 years

Exclusion criteria

  • Previous myocardial infarction (MI). This will include ST-elevation MI (STEMI) and non-ST-elevation MI (NSTEMI)
  • Known coronary artery disease - prior coronary revascularization
  • Known documented peripheral arterial disease
  • Previous stroke

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

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

Treatment and study plan

Primary outcomes

  1. First cardiovascular event

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Yeo Khung Keong, MBBS

CONTACT

67048963

Yuen Yet Lee, Nursing

CONTACT

67042295

Sponsors and collaborators

Lead sponsor

National Heart Centre Singapore

Other

Registry information

Official study title

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

Acronym: SingHEART

Important dates

Study start
2015
Primary completion
2036
Study completion
2036
First posted
Jun 6, 2016
Registry last updated
Jun 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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