Cardiovascular and Pulmonary Imaging in SARS-CoV-2: A Study of the Heart, Lungs and Wellbeing After COVID-19.
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- The primary cardiac outcome is the proportion of patients with a diagnosis of myocardial inflammation (myocarditis).
研究概览
简要总结
One-in-four patients with COVID-19 pneumonia develop life-threatening heart problems. Through cardiovascular imaging and biomarkers analyses this study aims to evaluate whether COVID-19 infection results in heart injury. The investigators will also investigate which patients are at risk of heart injury as a result of COVID-19 and why only some patients suffer heart problems as a consequence of the infection. The study will also assess multisystem involvement including the lungs and kidneys.
详细描述
Our study is supported through the Chief Scientist Office Rapid Research in Covid-19 (RARC-19) programme. Our study will clarify the pathogenesis of cardiopulmonary injury, notably endotypes of myocardial injury including myocarditis, in patients with COVID-19.
The study involves a prospective, observational, multicentre, longitudinal cohort design.The investigators aim to minimise selection bias by adopting consecutive screening of all-comers hospitalised with COVID-19 and the eligibility criteria are broad. For example, severe renal dysfunction is not an exclusion criterion. The sample size is 180 patients enrolled at baseline with 160 attending for the primary outcome evaluation (cardiac imaging) at 28 days post-discharge. The investigators will use advanced cardiovascular imaging to identify the number (proportion) of patients with myocardial inflammation (myocarditis) that is sub-clinical (i.e. not diagnosed) or clinically overt. Cardiovascular MRI and CT coronary angiography will provide a comprehensive examination one month after discharge is intended to detect persisting cardiovascular complications and diagnose clinical endotypes. The investigators aim to clarify the pathological significance of serial changes in circulating troponin, NTproBNP and renal function. By correlating the MRI findings with troponin I and other measures of cardiovascular injury, such as NTproBNP, our results will inform care pathways that use these blood tests to guide the management of patients with COVID-19. Correlation of imaging findings with baseline clinical information, biomarkers, patient reported outcome measures and well-being in the longer term will help to clarify the clinical significance of cardiovascular complications in COVID-19. Since the design is observational, an interim analysis may be undertaken with the timing informed by the enrolment rate.
Longer term follow-up will include a 5-year visit, contingent on funding and ethics approval, and electronic health record linkage of vital status and episodes of NHS care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •History of hospital attendance or hospitalisation for COVID-19, confirmed by a clinical diagnosis, laboratory test e.g. PCR and/or a radiological test e.g. CT chest or chest X-ray
- •Age 18 years or more
- •Capacity to provide written informed consent
- •Able to comply with study procedures
排除标准
- •Contra-indication to CMR e.g. severe claustrophobia, metallic foreign body
- •Lack of informed consent
- •Women who are pregnant, breast-feeding or of child-bearing potential without a negative pregnancy test
结局指标
主要结局
The primary cardiac outcome is the proportion of patients with a diagnosis of myocardial inflammation (myocarditis).
时间窗: 28 days after discharge from hospital
Myocardial inflammation (or myocarditis) will be revealed by cardiovascular magnetic resonance imaging (MRI) according to contemporary guidelines including the modified Lake Louise Criteria. The endotypes of myocardial injury are 1) myocardial inflammation due to 1.1) viral myocarditis, 1.2) ischaemia, or 1.3) stress (Takotsubo) cardiomyopathy, 2) myocardial infarction, 3) indeterminate, or 4) none. The final diagnosis will be a consensus-based determination by an expert panel. This information will provide insights into the incidence, nature, time-course and clinical significance of cardiovascular involvement in patients with COVID-19. The clinical significance of our findings will be assessed through associations with patient reported outcome measures (PROMS) and health outcomes in the longer term.
The primary cardio-pulmonary outcome is the proportion of patients with thrombosis
时间窗: 28 days after discharge from hospital
Thrombosis of the right heart, pulmonary arteries and left heart will be determined contrast-enhanced CT chest, angiography and MRI.
次要结局
- Systemic inflammation(28 days after discharge from hospital, > 1 year post discharge (average 18-22 months))
- Endothelial activation and haemostasis(28 days after discharge from hospital, > 1 year post discharge (average 18-22 months))
- Myocardial injury(28 days after discharge from hospital, > 1 year post discharge (average 18-22 months))
- Myocardial stress(28 days after discharge from hospital, > 1 year post discharge (average 18-22 months))
- Vascular injury(28 days after discharge from hospital, > 1 year post discharge (average 18-22 months))
- Fibrin lysis(28 days after discharge from hospital, > 1 year post discharge (average 18-22 months))
- Coagulation(28 days after discharge from hospital, > 1 year post discharge (average 18-22 months))
- Platelet count(28 days after discharge from hospital, > 1 year post discharge (average 18-22 months))
- Renal function(28 days after discharge from hospital, > 1 year post discharge (average 18-22 months))
- Quantify myocardial perfusion as a measure of coronary microvascular function(28 days after discharge from hospital, > 1 year post discharge (average 18-22 months))
- Association of the primary outcome according to a prior history of cardiovascular disease or no history of prior cardiovascular disease.(28 days after discharge from hospital, > 1 year post discharge (average 18-22 months))
- Patient reported outcome measures (PROMS) - health status(1 year)
- PROMS - functional capacity(1 year)