NCT05033613

Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The coronavirus SARS-CoV-2 causing COVID-19 was pandemic since 2020. Vaccination is one of the most important measure to control the outbreak. The countries of the world started the vaccination since December, 2020. Taiwan started since March, 21st, 2021. Currently, Taiwanese people receive COVID-19 vaccination by either AZ or Moderna; Pfizer/BNT vaccine may import in the near future. The side effects post vaccination including injection site pain, fatigue, headache, myalgia, chills, arthralgia, fever, and so on. Incidence of side effects more frequent in young people than elders; more frequent in the first dose than second dose in AZ vaccine; more frequent in the second dose in Moderna or Pfizer/BNT vaccine. Taiwan V-watch is a system monitored by CDC for people proactive notification of side effects post COVID-19 vaccination. But it doesn't include the objective cardiovascular parameters, for example, heart rate, arrhythmia, blood pressure, central body temperature (ear temperature) and blood oxygen saturation level. This study aims to monitor the physiologic and psychologic effects, and side effects before and after COVID-19 vaccination in patients at high cardiovascular risk, including hypertension, hyperlipidemia, and type 2 diabetes, and arrhythmia or coronary artery disease. The investigators arrange two weeks of continuous home BP/HR monitoring (7 days pre- and post-vaccination) for evaluation of physiologic effects post vaccination. Due to fever noted in some people post-vaccination, the investigators also measure ear temperature, pulse oximetry, and environmental temperature and humidity, for the reference of BP monitoring. In conclusion, this study may provide important information of cardiovascular response and psychosocial effects after SARS-CoV-2 vaccination for proactive prevention of cardiovascular complications.

Conditions

• Pain
• Fatigue
• Headache
• Myalgia
• Chills
• Arthralgia
• Fever

Interventions

Type	Name	Description
OTHER	heart rate、arrhythmia、blood pressure、central body temperature (ear temperature) and blood oxygen saturation level.	heart rate、arrhythmia、blood pressure、central body temperature (ear temperature) and blood oxygen saturation level.

Timeline

• Start date: 2021-09-10
• Primary completion: 2022-12-29
• Completion: 2022-12-29
• First posted: 2021-09-05
• Last updated: 2021-09-16

Locations

1 site across 1 country: Taiwan