Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland (SETANTA)
研究概览
详细说明
Approximately 100 participants from primary care will be enrolled via General Practitioner (GP) or Primary Care Centers in Dublin. A patient information sheet (PIS) will be made accessible to participants recovering from COVID-19 via their GP practice inviting the participants to contact Cardiovascular Research Institute Dublin. The participants, subject to suitability, will be invited for a site visit over two days, where upon explicit consent being granted, the Investigators will proceed with data collection. The study population includes participants who are recovering from COVID-19 in the community.
Primary Objective
To investigate the incidence of cardiac abnormalities as assessed by cardiac magnetic resonance imaging in unselected participants after acute SARS-CoV-2 infection and correlation with immunological response and biomarkers of coagulation.
Secondary Objectives
- To investigate the incidence of SARS-CoV-2 immunity and
- To investigate the extent of coagulopathy persistent after acute SARS-CoV-2 infection.
Follow-up data collection points will be at 1, 6- and 12-months including assessment of major adverse cardiovascular events (MACE) such as myocardial infarction (MI), revascularization, pulmonary embolism (PE), deep venous thromboembolism (DVT), incident heart failure and stroke. 'Patient reported outcome measures' via two quality of life (QOL) questionnaires will be administered at baseline and at 6 and 12 months.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Dublin、爱尔兰、D07 KWR1
- Cardiovascular Research Institute Dublin
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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:
- Patients 18 years or older
- Written informed consent
- Recent COVID-19 infection ≥ 6 weeks and ≤ 12 months before enrolment, as evidenced by positive reverse-transcriptase polymerase chain reaction (RT-PCR) SARS-CoV-2 swab
Exclusion Criteria:
- Prior history of myocarditis or ischemic heart disease
- General contraindications for Magnetic Resonance Imaging e.g. Magnetic Resonance unsafe pacemaker, devices, implants etc.
- Contraindication to gadolinium (estimated glomerular filtration rate <30 ml/min)
- Contraindication to Regadenoson, including cardiac conduction disease, asthma, seizures, pregnancy or breast-feeding
- Inability to provide written informed consent, to fill out the safety questionnaire, or to fully cooperate with the scan and breath holds
- Insufficient Cardiac Magnetic Resonance image quality
学习计划
研究是如何设计的？
设计细节
- 观测模型：仅案例
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Cases
Cases - Recent COVID-19 infection ≥ 6 weeks and ≤ 12 months before enrolment, as evidenced by positive reverse-transcriptase polymerase chain reaction (RT-PCR) SARS-CoV-2 swab
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The Cardiac MRI protocol consists of static T2 weighted in all three planes and T2 weighted imaging with fat saturation in the short axis plane.
其他名称：
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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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Left ventricular (LV) ejection fraction
大体时间：Day 0
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Cardiac Magnetic Resonance finding
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Day 0
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LV end diastolic volume
大体时间：Day 0
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Cardiac Magnetic Resonance finding
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Day 0
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Right ventricular ejection fraction
大体时间：Day 0
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Cardiac Magnetic Resonance finding
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Day 0
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Native T1, T2
大体时间：Day 0
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Cardiac Magnetic Resonance finding
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Day 0
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Late gadolinium enhancement
大体时间：Day 0
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Cardiac Magnetic Resonance finding
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Day 0
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Pericardial abnormalities
大体时间：Day 0
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Cardiac Magnetic Resonance finding
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Day 0
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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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Immunity parameters
大体时间：Day 0
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Anti-SARS-CoV-2 total antibody testing
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Day 0
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Markers of coagulation and endothelial cell activation
大体时间：Day 0
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Including fibrinogen, D-dimer, von Willebrand factor antigen, von Willebrand factor propeptide, soluble thrombomodulin, activated protein C, and cytokine arrays
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Day 0
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合作者和调查者
调查人员
- 首席研究员：Robert A Byrne, MB BCh PhD、CVRI Dublin at Mater Private Hospital
- 首席研究员：Roisin Colleran, MB BCh、CVRI Dublin at Mater Private Hospital
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 (预期的)
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
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