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

S

Singapore Health Services (SingHealth)

Status

Enrolling

Conditions

Myocardial Infarction

Study type

Observational

Funder types

Other

Identifiers

NCT02791152
2015/2601

Details and patient eligibility

About

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

Full 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

Enrollment

1,000 estimated patients

Sex

All

Ages

21 to 69 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Yuen Yet Lee, Nursing; Yeo Khung Keong, MBBS

Data sourced from clinicaltrials.gov

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