Covid-19 Effects on ARTErial StIffness and Vascular AgiNg
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- PWV
研究概览
简要总结
The purpose of the study is to evaluate the presence of early vascular aging 6 months and 12 months after COVID-19 infection.
详细描述
After being informed about the study and potential risks, all eligible patients giving written informed consent will undergo a comprehensive non-invasive assessment of vascular and cardiac function 6 months and 12 months after COVID-19 infection. Cardiovascular events and mortality will be collected 2, 5 and 10 years after inclusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age >18 years, both sexes;
- •written informed consent;
- •affiliation to a social security regime;
- •a recent diagnosis of COVID19 (6±3 months) proven by PCR or serology (for group 1,2,3)
- •hospitalization in intensive care unit for COVID19 (for group 1)
- •hospitalization in a medicine unit for COVID19 (for group 2)
- •no hospitalization for COVID19 or hospitalization less than 24h (for group 3)
- •a negative test for SARS-nCOV2 infection (PCR or serology)(for group 4)
排除标准
- •Age <18 years
- •Inability to express consent of the study
- •Diseases carrying out a life -expectancy <1 year according to clinical judgment
- •Pregnancy and breastfeeding
- •Foreseen inability to attend scheduled visits
研究组 & 干预措施
Group 1
Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in intensive care unit
干预措施: carotid-femoral pulse-wave velocity (Diagnostic Test)
Group 2
Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in a medicine unit
干预措施: carotid-femoral pulse-wave velocity (Diagnostic Test)
Group 3
Patients with confirmed infection by SARS-Cov-2, not requiring hospitalization
干预措施: carotid-femoral pulse-wave velocity (Diagnostic Test)
Group 4
- individuals having performed a test for SARS-Cov-2 infection, but resulted to be negative
干预措施: carotid-femoral pulse-wave velocity (Diagnostic Test)
结局指标
主要结局
PWV
时间窗: 12 months after COVID19 infection
carotid-femoral pulse wave velocity measured by application tonometry
PWV change
时间窗: difference between PWV at 12 and 6 months after COVID19 infection
carotid-femoral pulse wave velocity measured by application tonometry
PWV
时间窗: 6 months after COVID19 infection
carotid-femoral pulse wave velocity measured by application tonometry
次要结局
- carotid femoral and hearth carotid change(6 months after COVID19 infection)
- wave separation/wave intensity analysis (WSA/WIA)(12 months after COVID19 infection)
- WSA/WIA change(difference between WSA/WIA at 12 and 6 months after COVID19 infection)
- cardiac diastolic dysfunction(12 months after COVID19 infection)
- cardiac diastolic dysfunction change(difference between cardiac diastolic dysfunction at 12 and 6 months after COVID19 infection)
- myocardial stiffness(12 months after COVID19 infection)
- myocardial stiffness change(difference between myocardial stiffness at 12 and 6 months after COVID19 infection)
- arterial distensibility(12 months after COVID19 infection)
- arterial distensibility change(difference between arterial distensibility at 12 and 6 months after COVID19 infection)
- brachial artery FMD(12 months after COVID19 infection)
- brachial artery FMD change(difference between FMD at 12 and 6 months after COVID19 infection)
- central blood pressure(12 months after COVID19 infection)
- central blood pressure (BP) change(difference between central BP at 12 and 6 months after COVID19 infection)
- arterial distensibility(6 months after COVID19 infection)
- brachial artery FMD(6 months after COVID19 infection)
- central blood pressure(6 months after COVID19 infection)
- wave separation/wave intensity analysis (WSA/WIA)(6 months after COVID19 infection)
- cardiac diastolic dysfunction(6 months after COVID19 infection)
- myocardial stiffness(6 months after COVID19 infection)