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

Recruiting

• Conditions: Myocardial Infarction

• Registration Number: NCT02791152
• Lead Sponsor: National Heart Centre Singapore

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

Study Timeline

• Status Verified: 2015-09
• Study Start: 2015-10
• Study First Submitted: 2016-05-31
• Study First Submitted QC: 2016-05-31
• Last Update Submitted: 2016-05-31
• Study First Posted: 2016-06-06
• Last Update Posted: 2016-06-06
• Primary Completion: 2036-12
• Study Completion: 2036-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First cardiovascular event	1 year

Trial Locations

Locations (1)

National Heart Centre Singapore; 🇸🇬 Singapore, Singapore