Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Left ventricular (LV) ejection fraction
研究概览
简要总结
SETANTA study will investigate the incidence of cardiac abnormalities as assessed by cardiac magnetic resonance imaging in unselected patients after acute SARS-CoV-2 infection and correlation with immunological response and biomarkers of coagulation.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Left ventricular (LV) ejection fraction
时间窗: Day 0
Cardiac Magnetic Resonance finding
LV end diastolic volume
时间窗: Day 0
Cardiac Magnetic Resonance finding
Late gadolinium enhancement
时间窗: Day 0
Cardiac Magnetic Resonance finding
Pericardial abnormalities
时间窗: Day 0
Cardiac Magnetic Resonance finding
Native T1, T2
时间窗: Day 0
Cardiac Magnetic Resonance finding
Right ventricular ejection fraction
时间窗: Day 0
Cardiac Magnetic Resonance finding
次要结局
- Markers of coagulation and endothelial cell activation(Day 0)
- Immunity parameters(Day 0)