Clinical Significance of Subclinical Myocardial Involvement in Recovered COVID-19 Patients Using Cardiovascular Magnetic Resonance (R-COVID-CMR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- The correlation of these myocardial characteristics to clinical symptoms at all time-points.
研究概览
简要总结
This is a prospective cohort study that aims to clinical significance of subclinical myocardial involvement in recovered COVID-19 patients using cardiovascular magnetic resonance.
详细描述
This study aims to:
- Determine the extent of myocardial involvement of COVID-19, as assessed by Cardiovascular Magnetic Resonance (CMR), 2 weeks after patient recovery, at 3-month post discharge and at 1-year post discharge.
- Correlate these myocardial characteristics to biventricular structure, function, blood biomarkers of inflammation, clinical symptoms, and functional capacity at all time points.
- Follow up recovered COVID-19 patients beyond the end of this study to assess for hard outcomes such as death, heart failure hospitalization, cardiac arrest and ventricular tachycardia/ fibrillation.
Recovered COVID-19 patients and age and gender matched controls subjects will be recruited.
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.
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 correlation of these myocardial characteristics to clinical symptoms at all time-points.
时间窗: 2 years
The correlation of these myocardial characteristics to biventricular structure at all time-points.
时间窗: 2 years
The correlation of these myocardial characteristics to biventricular function (CMR cine/strain) at all time-points.
时间窗: 2 years
The correlation of these myocardial characteristics to blood biomarkers of inflammation at all time-points.
时间窗: 2 years
The extent of myocardial involvement, as assessed by CMR tissue characterisation (T1/ T2/ ECV/ LGE), change from 2 weeks after patient recovery, at 3-months post discharge and at 1-year post discharge.
时间窗: 2 years
The correlation of these myocardial characteristics to functional capacity (6 minute walk test) at all time-points.
时间窗: 2 years
次要结局
- Follow-up patients beyond the end of this study to assess for hard outcomes such as death.(2 years)
- Follow-up patients beyond the end of this study to assess for hard outcomes such as heart failure hospitalisation.(2 years)
- Follow-up patients beyond the end of this study to assess for hard outcomes such as cardiac arrest.(2 years)
- Follow-up patients beyond the end of this study to assess for hard outcomes such as ventricular tachycardia/ fibrillation.(2 years)
研究者
Dr. Ng Ming-Yen
Clinical Assistant Professor
The University of Hong Kong