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

  • STATUS
    Recruiting
  • days left to enroll
    28
  • participants needed
    1500
  • sponsor
    National Taiwan University Hospital
Updated on 26 September 2021
diabetes
fever
hypertension
fatigue
myalgia
coronavirus
headache

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.

Details
Condition Pain, fevers, Headache, arthralgias, Chills, Myalgia, Chronic Leg Pain, Muscle Soreness, joint pain, pyrexia, Muscle Pain, Fatigue, Arthralgia, muscular pain, Post-Surgical Pain, pain, joint, muscle pains, ache, pain, muscle, tired, myalgias, hyperthermia, fatigued, Fever, Headaches, Pain (Pediatric), lack of energy, Acute Pain Service
Treatment heart rate、arrhythmia、blood pressure、central body temperature (ear temperature) and blood oxygen saturation level.
Clinical Study IdentifierNCT05033613
SponsorNational Taiwan University Hospital
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

People at high cardiovascular risk
Clinical diagnosis of hypertension
Clinical diagnosis of hyperlipidemia
Clinical diagnosis of type 2 diabetes
Clinical diagnosis of arrhythmia
Clinical diagnosis of coronary artery disease
Patients at the cardiology clinic

Exclusion Criteria

People who have been diagnosed by a doctor as unsuitable for vaccination
People with serious injuries or catastrophic illness, such as cancer patients
People who stay in bed for a long time and cannot take care of themselves
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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