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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05033613
• Other study ID #: 202107076RINA
• Status: Recruiting
• Start date: September 10, 2021
• Est. completion date: December 29, 2022

Study information

• Verified date: September 2021
• Source: National Taiwan University Hospital
• Contact: TA-CHEN SU, Doctor
• Phone: 886-2-2312-3456
• Email: lab.of.su[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 29, 2022
• Est. primary completion date: December 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthralgia
• Cardiovascular Diseases
• Chills
• COVID-19
• Fatigue
• Fever
• Headache
• Myalgia
• Pain

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	Chung-Shan

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the physiological effects of different type of COVID-19 vaccines	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
Primary	Compare whether the subjective side effects of different type of COVID-19 vaccines are different	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
Primary	Compare the psychological stress effects of different type of COVID-19 vaccines	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