Clinical trial NCT02791152: Effects of Physical Activity, Ambulatory Blood Pressure and Calcium Score on Cardiovascular Health in Normal People
Official title: SingHEART: Effects of Physical Activity, Ambulatory Blood Pressure and Calcium Score on Cardiovascular Health in Normal People
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction
Lead sponsor: National Heart Centre Singapore
Sponsor class: OTHER
First posted: 2016-06-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers age between 21 to 69 years old, Singapore citizens

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

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

Eligibility criteria: 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

Primary outcomes:
measure: First cardiovascular event
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
Study officials:
affiliation: National Heart Centre Singapore
name: Yeo Khung Keong, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bylstra Y, Lim WK, Kam S, Tham KW, Wu RR, Teo JX, Davila S, Kuan JL, Chan SH, Bertin N, Yang CX, Rozen S, Teh BT, Yeo KK, Cook SA, Jamuar SS, Ginsburg GS, Orlando LA, Tan P. Family history assessment significantly enhances delivery of precision medicine in the genomics era. Genome Med. 2021 Jan 7;13(1):3. doi: 10.1186/s13073-020-00819-1.