Clinical Significance of Subclinical Myocardial Involvement in Recovered COVID-19 Patients Using Cardiovascular Magnetic Resonance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- The extent of myocardial involvement, as assessed by CMR tissue characterisation (T1/ T2/ ECV/ LGE), 2 weeks after patient recovery, at 3-months post discharge and at 1-year post discharge.
研究概览
简要总结
Introduction:
Coronavirus disease 2019 (COVID-19) remains a major health issue resulting in >800,000 deaths as of 30th August 2020. A concerning discovery of COVID-19 is the involvement of the myocardium. Several case studies including one from our group (recent study publication in JACC Cardiovascular Imaging led by the principal investigator of this grant application) have demonstrated subclinical myocardial inflammation in patients using cardiac magnetic resonance imaging (CMR) who have recovered from COVID-19. Furthermore at a cellular level, a recent autopsy study indicated that the severe acute respiratory syndrome coronavirus-2 is present in the myocardial tissue. The study further described invasion and viral progeny occurring in the myocardial interstitial cells and as such is a concerning development with the longer-term implications being unknown. These concerns have been noticed by the cardiology and non-cardiology medical community, with some expressing concerns of a new cause for cardiomyopathy and heart failure secondary to COVID-195. Therefore, it is critical that further studies are conducted to determine the longer-term outcome for patients.
详细描述
COVID-19 Cardiovascular Complications:
So far, COVID-19 has been linked to myocarditis, myocardial infarction, thrombosis/ hypercoaguable state and reduced cardiac function. At an early stage of the COVID-19 pandemic, it became apparent that cardiac complications were quite prevalent in COVID-19 patients, with a study from Wuhan showing 28% of patients having raised troponin levels and that raised troponin levels were correlated with poor outcome including death. In three case series using CMR to evaluate patients, the prevalence of myocardial infarcts ranged from 0% to 12%, myocardial inflammation was present in 56% to 60% of patients and reduced LV function was present in up to 7% of patients.
Role of CMR Imaging in COVID-19:
CMR is unique amongst the cardiac imaging modalities in providing a comprehensive evaluation of the heart structure, function and tissue characterisation. The European Society of Cardiology recognises CMR as the gold standard for assessing cardiac systolic function and volumes due to the high reproducibility between observers. Thus it allows for differences in cardiac systolic function and volumes to be detected earlier and with smaller sample sizes compared to echocardiography. CMR's tissue characterisation capabilities are unavailable to other modalities, and does not require ionising radiation or radioactive tracers (unlike computed tomography or nuclear imaging), which is ideal for follow-up testing. It has multiple techniques to identify myocardial inflammation / oedema (eg. T2/T1 mapping), focal fibrosis (eg. late gadolinium enhancement [LGE] quantification), and diffuse fibrosis (extracellular volume or ECV quantification). The newest pixel-wise quantitative T1/T2-mapping techniques are also named by the ESC as one of six most innovative technologies to evaluate patients with heart failure.
Thus, in the context of COVID-19, CMR is well positioned to assess for myocarditis and its long-term consequences, such as the development of myocardial fibrosis, cardiac remodeling and ultimately dysfunction and failure. This is attested to by the American College of Cardiology and European Society of Cardiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recovered COVID-19 patients
- •Definition of recovered COVID-19 patient:
- •COVID-19 diagnosis = established by a positive reverse transcription polymerase chain reaction (RT-PCR) for severe acute respiratory syndrome coronavirus-2 [SARS-CoV2] and recovered from COVID-
- •Recovery = based on two criteria: (1) two negative nasopharyngeal swab RT-PCR results >24 hours apart and (2) absence of fever and improvement in respiratory symptoms.
- •Recovered non-COVID-19 patients with viral respiratory infections confirmed with viral polymerase chain reaction testing AND with a confirmed negative COVID-19 RT-PCR test.
- •Age and gender matched controls with no cardiac risk factors, not on cardiac medications, no history of myocardial infarction, heart failure or myocarditis, negative COVID-19 RT-PCR test and negative COVID-19 antibodies test.
- •Vaccination controls who planning to receive a 2-dose COVID-19 vaccine, with no history of myocardial infarction, heart failure or myocarditis AND with a confirmed negative COVID-19 RT-PCR test.
排除标准
- •Previous myocardial infarction or myocarditis unrelated to COVID-19 infection
- •History of heart failure unrelated to COVID-19 infection
- •Presence of pacemakers or implantable cardiac defibrillators
- •Any contraindication for CMR testing
- •Renal impairment with eGFR <45ml/min/1.73m2
- •Limited life expectancy <1 year, for example due to pulmonary disease, cancer or significant hepatic failure
- •Refusal or inability to sign an informed consent.
- •Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits
结局指标
主要结局
The extent of myocardial involvement, as assessed by CMR tissue characterisation (T1/ T2/ ECV/ LGE), 2 weeks after patient recovery, at 3-months post discharge and at 1-year post discharge.
时间窗: 1 year
The correlation of these myocardial characteristics to biventricular structure, function (CMR cine/strain), blood biomarkers of inflammation, clinical symptoms, and functional capacity (6 minute walk test) at all time-points
时间窗: 2 years
次要结局
- Number of Participants with followed-up beyond the end of this study to assess for hard outcomes such as death.(2 years)
- Number of Participants with cardiac arrest.(2 years)
- Number of Participants with ventricular tachycardia.(2 years)
- Rate of subclinical myocardial inflammation post COVID-19 vaccination.(2 years)
- Number of Participants with followed-up beyond the end of this study to assess for hard outcomes such as heart failure hospitalisation.(2 years)
- Number of Participants with ventricular fibrillation.(2 years)
研究者
Dr. Ng Ming-Yen
Clinical Assistant Professor
The University of Hong Kong