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临床试验/NCT05013931
NCT05013931Unknown不适用

Short-term Effect of COVID-19 Vaccine on Blood Pressure

Chinese University of Hong Kong0 个研究点目标入组 100 人开始时间: 2021年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
To investigate short-term effect of COVID-19 vaccination on blood pressure by conducting 24-hour ABPM

研究概览

简要总结

To investigate short-term effect of COVID-19 vaccination on blood pressure by conducting 24-hour ABPM

详细描述

Safety of coronavirus disease 19 (COVID-19) vaccines has been a concern. Despite safety profile of different vaccines demonstrated in phase 2/3 trials, there has been evolving evidence on adverse effects of some particular COVID-19 vaccines. One of the mostly known example is vaccine-induced thrombotic thrombocytopenia (VITT). Apart from the thrombotic risk of ChAdOx1 nCoV-19 vaccine, there has been studies providing the preliminary data on effect of mRNA-based COVID-19 vaccine on blood pressure.

A case series report was published on Hypertension in June 2021 on documented stage III hypertension within minutes of vaccination (mRNA vaccines) in a vaccination centre located in Switzerland. The study reported 9 subjects experienced a surge in blood pressure to stage III hypertension after vaccination. Yet the study had a few shortcomings. There was not baseline measurement of blood pressure. Surge of blood pressure shortly after vaccination could be due to nervousness or white coat effect. Thus surge of blood pressure within minutes of vaccination could be not due to vaccination. There was not long-term follow-up on blood pressure measurement after vaccination.

Further to the case series report, another prospective study in Italy investigated effect of mRNA vaccine on blood pressure and heart rate. The study was conducted as a survey. There was 5.3% of respondents (6/113) reported rise of home blood pressure of at least 10mmHg after 1st dose vaccination, compared with home blood pressure prior to vaccination. Among these subjects, 4 of them required anti-hypertensive medication intensification.

Yet there remains lack of evidence and detailed description on effect of COVID-19 vaccines and blood pressure before and after vaccination. Use of ambulatory blood pressure monitoring (ABPM) before and after vaccination helps to understand the details on short-term blood pressure changes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects who will be receiving COVID-19 vaccination
  • Subjects who understand Chinese to make an informed consent

排除标准

  • Skin condition around the cuff not suitable for long term cuff wearing (e.g. severe dermatitis, wound)

结局指标

主要结局

To investigate short-term effect of COVID-19 vaccination on blood pressure by conducting 24-hour ABPM

时间窗: 1 day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kelvin KF Tsoi

Associate Professor

Chinese University of Hong Kong

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