Cardiac COVID-19 Health Care Workers (CCC)
Cardiac Involvement in Coronavirus (SARS-Cov-2) Infected Health Care Workers: The CCC Study
研究概览
详细说明
Most people infected with SARS-CoV-2 experience mild, self-limiting symptoms that have been managed in an outpatient setting and therefore have not undergone routine cardiac evaluation with EKG or cardiac imaging test. Similarly, although the emphasis has been placed on evaluating patients with severe respiratory symptoms, most of these patients have also not undergone cardiac imaging tests and; therefore, in both scenarios, possible myocarditis has not routinely evaluated.
The present study is designed to characterize cardiac involvement in individuals who have overcome the SARS-CoV-2 infection.
For that aim, the study is designed as an observational cross-sectional study. The target population are HUSA healthcare workers who have overcome SARS-CoV-2 infection, either symptomatic or asymptomatic, either having required hospital admission or not. Participants will undergo a clinical evaluation, electrocardiogram (EKG), cardiac magnetic resonance (CMR) and blood analysis including NT-proBNP, troponin, cellular and humoral immunity and genetics.
Main objectives of the study are to address the prevalence of myocardial damage suggestive of myocarditis and to address the prevalence of pericarditis in HUSA health care workers; both related to the systemic immune response to SARS-CoV-2 infection. As secondary objectives the study will further address other cardiac affections including: rhythm or conduction disorders, ischemic heart disease, dilatation of the right chambers, valve disease and will analyze the relationship between humoral and cellular immunity and the presence of cardiac involvement, and the genetic susceptibility in the development of cardiac involvement after SARS-CoV-2 infection.
The study will recruit 141 participants: 47 symptomatic hospitalized health care workers, 47 asymptomatic non-hospitalized health care workers, 47 asymptomatic health care workers
研究类型
注册 (实际的)
联系人和位置
学习地点
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Salamanca、西班牙、37007
- University Hospital of Salamanca
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Have overcome the SARS-CoV-2 infection meeting any of the following criteria (i) positive result on a reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of a specimen collected on a nasopharyngeal swab followed by a second negative RT-PCR and at least 14 days from this negative RT-PCR; (ii) presence of IgM antibodies and negative RT-PCR after the antibody assessment; (iii) presence of neutralizing IgG antibodies and absence of IgM.
- stable clinical situation, which allows performing a CMR.
- signature of informed consent.
Exclusion Criteria:
- Presence of IgM antibodies without negative subsequent RT-PCR.
- Contraindications to perform RMC: (i) gadolinium allergy, (ii) presence of metallic material in the body, such as plates, screws, incompatible pacemakers, etc. (iii) claustrophobia, (iv) severe kidney failure, (v) severe liver failure, (vi) sickle cell anemia
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:横截面
队列和干预
团体/队列 |
干预/治疗 |
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Health care workers
Health care workers from the University Hospital of Salamanca who have passed SARS-CoV-2 infection.
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This is an observational design.
Participants have passed infection from SARS-CoV-2 and a cardiac assessment is performed.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Myocarditis
大体时间:up to 3 months
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Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance
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up to 3 months
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Pericarditis
大体时间:up to 3 months
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Prevalence of pericarditis assessed by clinical criteria
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up to 3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Atrial fibrillation
大体时间:up to 3 months
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Prevalence of atrial fibrillation on EKG
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up to 3 months
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Ischemic heart disease
大体时间:up to 3 months
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Prevalence of ischemic heart disease assessed by cardiac magnetic resonance
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up to 3 months
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Dilatation of right heart chambers
大体时间:up to 3 months
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Prevalence of dilatation of right heart chambers assessed by cardiac magnetic resonance
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up to 3 months
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Valvular hear disease
大体时间:up to 3 months
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Prevalence of valvular heart disease assessed by cardiac magnetic resonance
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up to 3 months
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Rhythm disorders
大体时间:up to 3 months
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Prevalence of prolonged QT interval on EKG
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up to 3 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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