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临床试验/NCT04625075
NCT04625075已完成不适用

Manganese-Enhanced Magnetic Resonance Imaging of MyOcardial injuRY in COVID 19 (MEMORY- COVID)

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2020年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Manganese MRI

研究概览

简要总结

Our understanding of the clinical manifestations of COVID-19 is growing on a daily basis and there is evidence that increased age, cardiovascular risk factors and cardiac comorbidity are strongly associated with poor outcomes. Furthermore, myocardial injury occurs and is associated with a much worse outcome and rapid increase in mortality. There have been several reports of myocarditis and heart failure following infection. The mechanisms of myocardial injury and its consequences are not well understood.

In an ongoing peer-reviewed and funded study, the investigators are evaluating the use of magnetic resonance imaging (MRI) to characterise and to understand the mechanisms of heart failure and myocarditis. Following strong encouragement by the British Heart Foundation, the investigators now propose to extend this investigation to patients who have recovered from COVID-19 infection to understand the mechanisms of myocardial injury that they have experienced. Using gadolinium and manganese-enhanced MRI combined with Computed tomography coronary angiography (CTCA), the investigators will assess the mechanisms and direct impact of myocardial injury in patients who have recovered from COVID-19 infection. This will help the investigators understand how best to manage individuals who demonstrate evidence of myocardial injury and potentially provide insights that could lead to novel treatment interventions to reduce such injury and improve patient outcomes.

详细描述

COVID-19 Pandemic This is the first major pandemic the modern world has faced since the Spanish Flu in 1918, with a profound impact on all aspects of society as we know it. Governments worldwide have put in place emergency plans to help tackle and reduce the rapid spread of the infection, with social isolation being implemented by most to varying degrees. As expected, healthcare systems are facing unprecedented challenges and real-time re-structuring. As well as focusing on the identification and management of critically unwell COVID-19 patients, healthcare organisations have the responsibility of protecting the public from infection and to continue the treatment of non COVID-19 related conditions. This has resulted in a complete reorganisation in how we deliver care, prioritising safety and infection control measures. In reality, this means cancelling routine clinics and procedures and has the potential to have a great impact on patient care.

COVID-19 The pool of evidence regarding this novel strain of coronavirus and the associated infection is growing as the condition unfolds. The current estimated case fatality rate varies between 1.4%-2.3%, with higher rates in the elderly, certain ethnic groups and those with co-morbidities. The largest case series from the Chinese Centre of Disease Control and Prevention reported 72,314 case records from suspected and confirmed cases. The clinical severity was reported as mild in 81.4%, severe in 13.9% and critical in 4.7%. Although clinical presentation of COVID-19 can be variable, most commonly symptoms resemble those of other viral respiratory tract infections: fever, cough, dyspnoea, myalgia and fatigue. In severe cases, COVID-19 is associated with bilateral pneumonia, acute respiratory distress syndrome (ARDS), and septic and cardiogenic shock, with higher mortality and morbidity seen in elderly and comorbid patients.

Patients with known cardiovascular risk factors or established cardiac problems are at higher risk of contracting severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2), and this confers a worse prognosis in COVID- 19 infection. It is difficult to establish the true link between COVID-19 and prevalence of cardiovascular complications due to the lack of testing in community and the cohort of patients who are admitted to secondary care, who are likely to be older and have co-morbidities and therefore are more likely to have pre-existing cardiac conditions and develop new cardiovascular complications.

COVID-19: Myocardial Injury Myocardial injury with necrosis can occur with and without overt ischaemia from acute myocardial infarction and is defined as an elevated plasma cardiac troponin concentration above the 99th centile. There are different mechanisms underlying acute myocardial injury; with ischaemia from an acute coronary syndrome and prolonged myocardial oxygen demand/supply imbalance being the most familiar. It is well recognised that an acute myocardial injury may occur in the absence of ischaemia due to a variety of cardiac and non-cardiac causes. Furthermore, this can be seen in critically unwell patients of varying aetiology and is a marker of poor prognosis.

Therefore determining the underlying mechanism is vital in guiding clinical care and improving outcomes. Myocardial injury is increasingly recognised in COVID-19 patients and, as anticipated, it correlates with severe cases and poor outcomes.5 In a cohort of 191 patients with confirmed COVID-19, plasma cardiac troponin concentrations were elevated in non survivors compared to survivors: 46% (23/50) compared to 1% (1/95) mortality.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • All subjects to be entered must:
  • ≥ 18 years of age
  • if female, be non-pregnant as evidenced by a urine pregnancy test or postmenopausal or surgically sterile
  • provide written informed consent after having received oral and written information about the study

排除标准

  • have a positive pregnancy test
  • women who are breast feeding
  • have a history of ongoing drug abuse or alcoholism
  • have a history of torsades or prolonged QT/QT corrected interval
  • high degree atrioventricular block (AVB, second or third degree)
  • atrial fibrillation or flutter
  • have New York Heart Failure Association (NYHA) Grade IV heart failure
  • have abnormal liver function tests (> x3 ULN) or a history of liver disease
  • have a baseline estimated glomerular filtration rate (eGFR) (of <30 mL/min/1.73 m2)
  • have uncontrolled hypertension (systolic blood pressure >200 mmHg)
  • have any contraindications to MRI, including implanted devices/pacemakers
  • be maintained on either a calcium channel blocker or digoxin
  • known diagnosis of pheochromocytoma

结局指标

主要结局

Manganese MRI

时间窗: 2 years

Measure manganese uptake

MRI with gadolinium

时间窗: 2 years

Measure late gadolinium enhancement

CTCA

时间窗: 2 years

Measure degree of coronary disease

Extra-cellular volume (ECV)

时间窗: 2 years

Measure T1 values to calculate ECV (%)

次要结局

  • Cardiac biomarkers(2 years)
  • Electrocardiogram(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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