Clinical trial NCT05033613: Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease
Official title: Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Fatigue
Headache
Myalgia
Chills
Arthralgia
Fever
Keywords: COVID-19 vaccination, Side effects
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 1500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients at high cardiovascular risk, including hypertension, hyperlipidemia, and type 2 diabetes, and arrhythmia or coronary artery disease.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Compare the physiological effects of different type of COVID-19 vaccines
timeFrame: From 1 Sep. 2021 to 1 Dec. 2022
measure: Compare whether the subjective side effects of different type of COVID-19 vaccines are different
timeFrame: From 1 Sep. 2021 to 1 Dec. 2022
measure: Compare the psychological stress effects of different type of COVID-19 vaccines
timeFrame: From 1 Sep. 2021 to 1 Dec. 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Chung-Shan
Study officials:
affiliation: National Taiwan University Hospital
name: TA-CHEN SU, Doctor
role: STUDY_CHAIR
References: