Evaluation of the Prevalence and Clinical Manifestation of SARS-CoV-2 Infection in a Population of Adult and Pediatric Patients With Congenital Heart Disease Not Treated Surgically, and in a Population of Pediatric Patients With Cardiomyopathy, Arrhythmic Pathology, or Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,376
- 试验地点
- 1
- 主要终点
- Severity of SARS-CoV-2 infection evaluation
研究概览
简要总结
The goal of this observational study, drug-free, cross-sectional, single-center is to describe the incidence and characteristics of the clinical course and any short- and medium-term complications of patients with congenital heart disease of medical interest, and pediatric patients with cardiomyopathy, arrhythmic pathology or pulmonary arterial hypertension who have been affected by Sars-Cov-2 disease. The secondary objective of the study is to identify risk factors for the development of moderate-severe forms of COVID-19 disease in the study population.
详细描述
This is an observational, drug-free, cross-sectional, single-centre study. All patients followed at our centre and suffering from congenital heart disease treated with only haemodynamic procedures haemodynamic procedures alone, as well as paediatric patients suffering from cardiomyopathy, pulmonary hypertension or arrhythmic pathology whose follow-up was still in progress at the time of the start of the pandemic (due to death or for reasonsof the patient). The structural collection of data necessary for the evaluation of targets will take place through the creation of a specific electronic archive, in which census of all patients who have undergone follow-up at our centre since 01/01/2005 at the time of study approval and still in follow-up at the time of the start of the pandemic.
Patients of all ages will be enrolled age, both paediatric and adult, followed at our centre. It is estimated to include in the study approximately 5000 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of all ages with congenital heart disease undergoing hemodynamic procedures at our center or in natural history
- •Pediatric patients with cardiomyopathy, arrhythmic disease, or hypertension pulmonary
- •Obtaining informed consent
- •Patients who have access to an e-mail address and a computer to complete the questionnaire
排除标准
- •Patients with congenital heart disease undergoing corrective or palliative surgical treatment
结局指标
主要结局
Severity of SARS-CoV-2 infection evaluation
时间窗: Upon completion of the questionnaire by patient on day 1
The presence of ongoing SARS-CoV-2 infection will be defined as detection of viral RNA to a molecular swab or the detection of specific antigen at an antigenic swab, while the presence of previous infection will be defined as the presence of seroconversion for SARS-CoV-2 at a quantitative serological test. Severity of SARS-CoV-2 infection will be defined at different forms: * Severe form: Admission to intensive care unit, need for invasive respiratory support, death * Moderate form: Need for hospitalization or home oxygen therapy, or Worsening of oxygen dependence in patients on chronic home oxygen therapy. * Mild form: Symptomatic patients who do not meet the criteria for moderate or severe disease. * Asymptomatic form: Patients with infection positivity who do not have symptoms of disease. The patients' medical history and clinical data, as reported in the questionnaire, will be evaluated to look for possible risk factors for the development of severe forms of COVID-19 disease.
次要结局
未报告次要终点