Effect of COVID-19 on Endothelial Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Natural logarithm of reactive hyperemia index (Ln-RHI)
研究概览
简要总结
COVID-19 disease (coronavirus disease 2019) primarily affects the respiratory system, using the angiotensin-converting enzyme 2 receptor. However, there is increasing evidence that COVID-19 can also affect the heart (myocardial injury, myocarditis, arrhythmias) and the vascular system, effects that may worsen the clinical outcome of patients.
The aim of this study is to assess the effect of COVID-19 on the patients' endothelial function, during the acute phase of the disease (inpatient), shortly after recovery (2 months) and in the mid-term (6 months). Evaluation of endothelial function will be performed non-invasively by the method of Peripheral Arterial Tonometry (PAT) using the EndoPAT2000 system (Itamar Medical, Israel).
This is a prospective, case-controlled, single-center clinical observational study.
The study will include adult patients who developed COVID-19 disease for whom admission for hospitalization was required, while the control group will consist of healthy volunteers matched for age, gender and cardiovascular risk factors.
Patients enrolled in the study will undergo the following visits:
- Visit 1: Hospitalization
- Visit 2: 2 months after discharge
- Visit 3: 6 months after discharge
- Visit 4: 1 year after discharge Patients will be subjected to measurement of the reactive hyperemia index with the EndoPAT2000 system in Visits 1, 2 and 3.
The aim of the study is to compare the endothelial function between the two groups (COVID-19 vs. Controls).
详细描述
- Introduction COVID-19 disease (coronavirus disease 2019) primarily affects the respiratory system, using the angiotensin-converting enzyme 2 receptor. However, there is increasing evidence that COVID-19 can also affect the heart (myocardial injury, myocarditis, arrhythmias) and the vascular system, effects that may worsen the clinical outcome of patients.
Regarding COVID-19, there is increasing evidence of endothelial dysfunction, both directly due to direct infection of the vascular endothelium by the SARS-COV-2 virus (endothelitis), and indirectly due to the systemic inflammatory response and cascade of cytokines.
In the context of this study, the evaluation of endothelial function will be performed non-invasively by the method of Peripheral Arterial Tonometry (PAT) using the EndoPAT2000 system (Itamar Medical, Israel). The EndoPAT system quantifies the endothelium-dependent pulsatile arterial volume changes. During the examination, plethysmography biosensors are placed in the right and left patient's index fingers. Subsequently, arterial tone is measured in three phases:
A. at rest (baseline) B. during ischemia caused by a cuff inflated in one of the two arms at a level above that of systolic blood pressure for a period of 5 minutes C. during the phase of reactive hyperemia after the lifting of the arterial blockade by deflating the cuff The arterial tone signals detected in the above phases of the examination by the plethysmography biosensors are converted into digital signals for each upper limb and the EndoPAT2000 system software finally calculates the hyperemic vascular response (Ln Reactive Hyperemia Index-LnRHI). Endothelial dysfunction is defined as LnRHI≤0.51. 2. Aim of the study The aim of this study is to assess the effect of COVID-19 on the patients' endothelial function, during the acute phase of the disease (inpatient), shortly after recovery (2 months) and in the mid-term (6 months). 3. Methods This is a prospective, case-controlled, single-center clinical observational study.
The study will include adult patients who developed COVID-19 disease for whom admission for hospitalization was required, while the control group will consist of healthy volunteers matched for age, gender and cardiovascular risk factors.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18 years
- •Documented SARS-COV-2 infection with PCR test
- •Need for hospitalization in a COVID clinic
- •Informed written consent
排除标准
- •Inability to cooperate for peripheral arterial tonometry
- •Hemodynamic instability
- •High probability of non-compliance with the procedures of the study
- •Reduced life expectancy <1 year
- •Established atherosclerotic cardiovascular disease
- •Pregnancy, postpartum
- •Alcoholism
结局指标
主要结局
Natural logarithm of reactive hyperemia index (Ln-RHI)
时间窗: 2 months after discharge
Endothelial dysfunction is defined as LnRHI≤0.51
次要结局
- Area under the Curve (AUC) of the Reactive Hyperemia index (RHI) measurements during hospitalization, at 2 months after discharge and at 6 months after discharge.(At 6 months after discharge)
- Rate of endothelial dysfunction (LnRHI≤0.51)(At 6 months after discharge)
- Reactive Hyperemia Index (RHI)(At 6 months after discharge)
- Change in RHI index (ΔRHI) from hospitalization to 6 months(At 6 months after discharge)
- Incidence of thrombotic events(Up to 12 months after discharge)
- Mortality(Up to 12 months after discharge)
- Incidence of cardiovascular events(Up to 12 months after discharge)
- Natural logarithm of reactive hyperemia index (Ln-RHI)(During hospitalization (up to day 10))
- Duration (days) of hospitalization for COVID-19(Predischarge (up to 3 months))
研究者
Athanasios Moulias
Principal Investigator
University Hospital of Patras