Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 984
- 试验地点
- 42
- 主要终点
- Presence of rhythmic risk markers bye the questionnaire
研究概览
简要总结
As of March 2020, COVID-19 has become a global pandemic, halting athletic competition worldwide.
Reports from China show a high prevalence of cardiac involvement in patients with severe SARS-CoV-2 infection. These cardiac forms were found to be closely associated with adverse outcomes. The use of Magnetic resonance Imaging (MRI) had allowed to show that cardiac dysfunction could be mediated by myocardial inflammation (i.e. myocarditis). The direct implication of the virus was demonstrated with Severe Acute Respiratory Syndrome (SARS)-CoV-2 being detected on myocardial biopsies in a patient with severe heart failure.
The experience with other viruses causing acute myocarditis shows that there is a high rate of undetected injuries. Indeed, although severe heart failure can be present at the acute stage, acute viral myocarditis is most commonly pauci or asymptomatic, but still leaving occult myocardial scars visible on MRI, and exposing to higher risks of ventricular arrhythmia and sudden cardiac death over the long term.
Although athletes are younger and have fewer comorbidities than the general population and therefore are at lower risk for severe disease or death, there is a critical and urgent need to assess the prevalence of occult scars in the population of high-level athletes returning to training after the SARS-CoV-2 pandemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High level athlete,
- •Of both sexes and age ≥ 18 years,
- •Affiliated to or beneficiary of a social security system,
- •Free, informed, written consent signed by the participant and the investigating physician (no later than the day of inclusion and before any examination required by the research),
- •Effective method of contraception for women with childbearing capacity.
排除标准
- •History of ventricular arrhythmia, myocarditis, identified coronary artery disease or documented myocardial fibrosis,
- •Pregnant or breastfeeding women,
- •Person unable to give informed consent,
- •Person deprived of liberty by judicial or administrative decision,
- •Adults subject to a legal protection measure (guardianship, curator, safeguard of justice).
- •Specific exclusion criteria for the MRI component (Contraindications):
- •Subject with an implantable pacemaker or defibrillator, intraocular metallic foreign body, intracranial metallic clip, pre 6000 Starr-Edwards type cardiac valve prosthesis, or biomedical device such as insulin pump or neurostimulator,
- •Hypersensitivity to gadolinium or to one of the excipients of the contrast product used,
- •Claustrophobic subjects or those unable to remain in an immobile lying position for 30 minutes,
- •Renal insufficiency with creatinine clearance of less than 30 ml/min,
- •A patient whose shoulder width does not allow installation in the MRI machine.
结局指标
主要结局
Presence of rhythmic risk markers bye the questionnaire
时间窗: Day 0
Questionnaire looking for heart palpitations, chest pain/pressure and shortness of breath.
Evaluation by resting ECG of rhythmic risk marker : repolarization disorders
时间窗: Day 0
Presence or absence of repolarization disorders
Evaluation by resting ECG of rhythmic risk marker : inverted T waves
时间窗: Day 0
Presence or absence of inverted T waves
Presence of rhythmic risk markers bye ECG holter
时间窗: Day 0
VES, especially with short coupling (\<300ms), falling on the T wave, width \> 160ms, complex shapes (repetitive, multiple morphologies, instantaneous cycle \>200bpm), ventricular tachycardias (VTs). Ventricular arrhythmias are quantified.
Evaluation by resting ECG of rhythmic risk marker : ST segment abnormalities
时间窗: Day 0
Presence or absence of ST segment abnormalities
Evaluation by resting ECG of rhythmic risk marker : ventricular extrasystoles (VES)
时间窗: Day 0
Presence or absence of VES. Ventricular extrasystoles especially with short coupling (\<300ms), falling on the T wave, width \> 160ms, complex forms (repetitive, several morphologies, instantaneous cycle \>200bpm)
Presence of rhythmic risk markers bye ECG monitoring during games and trainings
时间窗: Day 0
In case of moderate arrhythmia on stress test and/or Holter ECG, ECG monitoring during training sessions and matches is carried out with analysis of the tracings collected, in search of more sustained arrhythmia, particularly at the ventricular level.
Presence of rhythmic risk markers by pharmacological tests and/or electrophysiological exploration
时间窗: Day 0
If the risk is perceived as very high, pharmacological tests (Isuprel®) and/or electrophysiological exploration may be performed during hospitalization, in search of dangerous rhythm disorders, particularly at the ventricular level.
Evaluation by resting ECG of rhythmic risk marker : QRS fragmentation
时间窗: Day 0
Presence or absence of QRS fragmentation
Presence of rhythmic risk markers bye the stress test
时间窗: Day 0
VES, especially with short coupling (\<300ms), falling on the T wave, width \> 160ms, complex shapes (repetitive, several morphologies, instantaneous cycle \>200bpm), ventricular tachycardias (VT). The analysis focus on the exercise period, and the recovery period. Ventricular arrhythmias will be quantified.
Evaluation by resting ECG of rhythmic risk marker : ventricular tachycardia (VT)
时间窗: Day 0
Presence or absence of VT.
次要结局
- Presence of myocardial fibrosis by injected MRI(Month 3)
- Research of inflammation markers(Month 5)
- Presence of transmural localization of myocardial fibrosis by injected MRI(Month 3)
- Measurement of cardiac scar size by injected MRI(Month 3)
- Search for constitutional genetic biomarkers(Month 5)