PainNCT05033613
Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease
An observational study of Pain and Fatigue, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- What is being tested?
- heart rate、arrhythmia、blood pressure、central body temperature (ear temperature) and blood oxygen saturation level.
- How many people
- 1,500 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Sep 2021to 29 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients at high cardiovascular risk, including hypertension, hyperlipidemia, and type 2 diabetes, and arrhythmia or coronary artery disease.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Chung-Shan, 10002
Su Ta Chen, PI, 0223123456 ext. 66719, lab.of.su@gmail.com
About this study
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.
- Being tested
- heart rate、arrhythmia、blood pressure、central body temperature (ear temperature) and blood oxygen saturation level.
- Keywords
- COVID-19 vaccination, Side effects
- Medical subject headings
- Pain, Fatigue, Headache, Myalgia, Chills, Arthralgia, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart rate、arrhythmia、blood pressure、central body temperature (ear temperature) and blood oxygen saturation level.Other
heart rate、arrhythmia、blood pressure、central body temperature (ear temperature) and blood oxygen saturation level.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From 1 Sep. 2021 to 1 Dec. 2022
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.
Measured: From 1 Sep. 2021 to 1 Dec. 2022
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.
Measured: From 1 Sep. 2021 to 1 Dec. 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start10 Sep 2021
- Primary completion29 Dec 2022 (estimated)
- Study completion29 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TA-CHEN SU, Doctor, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033613
- Sponsor's protocol ID
- 202107076RINA
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT05033613
- Acronym / sponsor ID
- 202107076RINA
- Keywords
- COVID-19 vaccination, Side effects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 29 Dec 2022 (estimated)
- Study completion
- 29 Dec 2022 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients at high cardiovascular risk, including hypertension, hyperlipidemia, and type 2 diabetes, and arrhythmia or coronary artery disease.
Key inclusion criteria (7 listed)
- People at high cardiovascular risk.
- Clinical diagnosis of hypertension
- Clinical diagnosis of hyperlipidemia
- Clinical diagnosis of type 2 diabetes
- Clinical diagnosis of arrhythmia
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
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).
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TA-CHEN SU, Doctor study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Fatigue, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TA-CHEN SU, Doctor (886-2-2312-3456 ext. 66719, lab.of.su@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the physiological effects of different type of COVID-19 vaccines (time frame: From 1 Sep. 2021 to 1 Dec. 2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.