Effect of CoVid-19 and Exercise on Myocardial Fibrosis and Ventricular Arrhythmias (CovidEx)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Percentage of athletes with LGE on CMR
研究概览
简要总结
COVID-19 can cause myocarditis, which can cause myocardial fibrosis. This has been shown to increase mortality and morbidity among athletes. Several efforts have been made to guide sports participation after COVID-19, but not much scientific evidence is present to back-up those guidelines. The current initiative aims gain a heightened insight in this matter.To identify the presence of fibrosis athletes who recovered from COVID-19 will undergo CMR (Cardiac MRI). All athletes will also undergo echocardiography, 5-day Holtermonitoring among others. This will allow to determine whether differences between those with and those without fibrosis are present. If fibrosis is present, athletes will be offered an implantation of a very small monitoring device that will be able to detect arrhythmias with a much higher sensitivity. Also an exercise echocardiography will be performed, to determine the safety of continuation of athletic efforts.
Amendment:
Recently myocarditis and pericarditis have also been observed after the administration of mRNA-vaccines, specifically after the second dose. The effect of vaccination on exercise capacity is less clear. To investigate this we propose to amend the inclusion criteria for COVIDEX with "athletes undergoing or having undergone COVID vaccination"
详细描述
Baseline investigations will depend on the clinical presentation of the athlete. Three groups are identified:
- Asymptomatic/mildly symptomatic: anosmia, ageusia, headache, mild fatigue, fever ≤3d, myalgias ≤3d , mild upper respiratory tract illness, and mild gastrointestinal illness
- Moderate to severe symptoms: at least 2 of: persistent fever ≥4d, chills ≥4d, myalgias ≥4d, lethargy impairing activities of daily life (ADL) ≥4d, dyspnea during ADL ≥4d, and chest tightness ≥4d. Or cardiac symptoms: dyspnea, exercise intolerance, chest tightness, dizziness, (pre)syncope, and (new onset) palpitations.
- Hospitalized: all athletes admitted for COVID-19, whether or not on the intensive care unit.
- Group 1 will undergo a thorough history, clinical examination, ECG, laboratory tests for hs-Troponin T (TnT) and hsCRP, echocardiography at rest, 5-day-Holter and CMR. These examinations will take place at least 30 days after the first symptoms or positive test. Follow-up will be performed as pointed out with the grey crosses in the table. Depending on the results further investigation may be required (as in group 2 and 3). This part of the study is interventional in nature (not according to standard of care in those individuals).
- Groups 2 and 3 will undergo a more extensive evaluation: a thorough history, clinical examination, ECG, laboratory tests for hs-TnT and hsCRP, echocardiography at rest, CardioPulmonary Exercise Test (CPET), 5-day-Holter, late potentials and CMR.
If in any athlete the CMR shows signs of fibrosis or myocarditis, an exercise echocardiography will be performed additionally. Those subjects will be part of a more extensive follow-up schedule (both white and grey in the table) In the case of the presence of a non-ischemic pattern of Late Gadolinium Enhancement (LGE) or raised myocardial T2 and normal of only mildly contractile reserve, implantation of an Implantable Loop Recorder (ILR) will be performed as a part of the study. This then will be remotely followed-up through telemonitoring. Other athletes (and those who refuse an ILR will receive a 5d-Holter monitoring.
Amendment:
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
- •Athletes (professional or recreational but aiming to compete at a national or international level), performing mixed-type or endurance sports as defined by Pelliccia et al. who:
- •have recovered from a proven (either by PCR (Polymerase Chain Reaction), serology or chest Computed Tomography) COVID-19 infection
- •are more than 1-month post onset of symptoms or the first positive PCR and
- •are willing to start (or are) exercising again
排除标准
- •known prior cardiac fibrosis
- •known or newly diagnosed coronary artery disease
- •allergy or contraindications for gadolinium contrast.
- •unwillingness or impossibility to give informed consent
- •Presence of edema on the CMR
结局指标
主要结局
Percentage of athletes with LGE on CMR
时间窗: 6months - 3 years post COVID diagnosis
Arrhythmic Burden on ILR
时间窗: 6months to 2 to3 years post implantation (depending on device longevity)
Arrhythmic Burden on 5d Holter
时间窗: At 3 years
次要结局
- Occurrence of (pre)syncope or SCD(throughout the duration of the study, preamble is 3 years)
- Long-term evolution of cardiac function on echo/CMR: ejection fraction(reevaluation at 3 years)