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临床试验/NCT04828629
NCT04828629进行中(未招募)不适用

Complications and the Influence of COVID-19 on Myocardial Function and Exercise Capacity

Polish Mother Memorial Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年12月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Prognosis in patients who have recovered from COVID-19

研究概览

简要总结

The subject of the study is the impact of COVID-19 on the indicators of myocardial efficiency and exercise capacity. As a result of the observed dependencies, it will be possible to start an appropriate diagnostic procedure early, select personalized treatment and develop a model of cardiological care for people with a history of SARS-CoV-2 infection and improve the quality and extend their life.

详细描述

About 100 adult patients hospitalized in the Department of Cardiology and Congenital Heart Diseases of Adults who had recovered from COVID-19 will be included in the study. Selected prognostic factors will be analyzed, among others: demographic data of the patient, physical examination, symptoms, co-morbidities, results of selected laboratory tests, lung imaging (X-ray or computed tomography) selected electrocardiographic and echocardiographic data, patient's cooperation with the doctor, treatment applied, parameters in the spiroergometric study, body mass analysis. One year after inclusion in the study, a control hospitalization will be performed. The same factors will be analyzed.

研究设计

研究类型
Observational
观察模型
Other
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

  • Age equal to or older than 18 years
  • infection with the SARS-CoV-2 in past medical history
  • current hospitalization

排除标准

  • severe hypertension;
  • unstable angina;
  • acute pulmonary embolism;
  • decompensated heart failure;
  • recent myocardial infarction;
  • unstable heart rhythm disturbances;
  • acute myocarditis or pericarditis;
  • active endocarditis;
  • advanced atrioventricular block;
  • diagnosis of cardiomyopathy (hypertrophic, dilated, restrictive, peripartum, arrhythmogenic)
  • lysosomal storage disorders
  • severe hyper- and hypothyroidism
  • pregnancy and lactation
  • chronic kidney disease (IV, V stadium according to NKF) and dialysis treatment
  • documented neoplastic process
  • the patient's inability to cooperate and/or provide informed consent to participate in a research
  • alcohol and drug abuse
  • active autoimmune disease
  • treatment using immunosuppressants, cytostatic drugs, glucocorticosteroids, or antiretroviral drugs
  • a history of bone marrow transplant or other organ transplant, treatment with blood products within the last 6 months
  • active systemic infection
  • HBV, HCV or HIV carrier or positive for HbS antigen or antibodies to HCV
  • surgery or serious injury within the last month
  • patients who did not express their informed consent to participate in the study

结局指标

主要结局

Prognosis in patients who have recovered from COVID-19

时间窗: 12 months after inclusion in the study

A control hospitalization will be conducted with patients. The same prognostic factors will be analyzed: physical examination, symptoms, co-morbidities, treatment applied, results of selected laboratory tests, lung imaging (X-ray or computed tomography) selected electrocardiographic (ECG) and echocardiographic data, parameters in the spiroergometric study, body mass analysis.

次要结局

  • The imaging of pulmonary changes in patients who have recovered from COVID-19(12 months after inclusion in the study)
  • Review of selected Holter ECG monitoring data in patients who have recovered from COVID-19(12 months after inclusion in the study)
  • Review of selected laboratory tests in patients who have recovered from COVID-19(12 months after inclusion in the study)
  • Review of parameters in the spiroergometric study in patients who have recovered from COVID-19(12 months after inclusion in the study)
  • Body mass analysis in patients who have recovered from COVID-19(12 months after inclusion in the study)
  • Review of selected echocardiographic data in patients who have recovered from COVID-19(12 months after inclusion in the study)

研究者

发起方
Polish Mother Memorial Hospital Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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