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

NCT ID: NCT02791152

Last Updated: 2016-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2036-12-31

Brief Summary

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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

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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

Conditions

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Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart Centre Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yeo Khung Keong, MBBS

Role: PRINCIPAL_INVESTIGATOR

National Heart Centre Singapore

Locations

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National Heart Centre Singapore

Singapore, Singapore, Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Yeo Khung Keong, MBBS

Role: CONTACT

67048963

Yuen Yet Lee, Nursing

Role: CONTACT

67042295

Facility Contacts

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Khung Keong Yeo, MBBS

Role: primary

67048963

References

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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.

Reference Type DERIVED
PMID: 33413596 (View on PubMed)

Other Identifiers

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2015/2601

Identifier Type: -

Identifier Source: org_study_id

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