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

September 14, 2021 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Chung-Shan
      • Taipei, Chung-Shan, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients at high cardiovascular risk, including hypertension, hyperlipidemia, and type 2 diabetes, and arrhythmia or coronary artery disease.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the physiological effects of different type of COVID-19 vaccines
Time Frame: From 1 Sep. 2021 to 1 Dec. 2022
Compare the physiological effects of different type of COVID-19 vaccines, including cardiovascular aspects, blood pressure, heartbeat, blood oxygen, whether there is arrhythmia, whether there are changes in blood oxygen concentration and core body temperature (ear temperature).
From 1 Sep. 2021 to 1 Dec. 2022
Compare whether the subjective side effects of different type of COVID-19 vaccines are different
Time Frame: From 1 Sep. 2021 to 1 Dec. 2022
Compare whether the subjective side effects of different type of COVID-19 vaccines are different, including fever, headache, dizziness, drowsiness, insomnia, palpitations, arrhythmia, nausea, vomiting, tiredness, pain, redness, heat or swelling at the injection site, difficulty breathing, muscles soreness, muscle weakness, abdominal pain, diarrhea, etc.
From 1 Sep. 2021 to 1 Dec. 2022
Compare the psychological stress effects of different type of COVID-19 vaccines
Time Frame: From 1 Sep. 2021 to 1 Dec. 2022
Compare the psychological stress effects of different type of COVID-19 vaccines, choose to use the CES-D (The Center for Epidemiologic Studies Depression Scale) Questionnaire and PSQI (The Pittsburgh Sleep Quality Index), to measure and check whether there are differences.
From 1 Sep. 2021 to 1 Dec. 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Chair: TA-CHEN SU, Doctor, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2021

Primary Completion (Anticipated)

December 29, 2022

Study Completion (Anticipated)

December 29, 2022

Study Registration Dates

First Submitted

September 1, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202107076RINA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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