Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19 (ASCCOVID19)
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.
調査の概要
状態
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Angoulême、フランス、16000
- Training center Soyaux Angoulême XV Rugby
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Aurillac、フランス、15000
- Training Center Stade Aurillacois
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Bayonne、フランス、64104
- Aviron Bayonnais Rugby Pro Training Center
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Biarritz、フランス、64200
- Biarritz Olympique Pays Basque training center
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Bordeaux、フランス、33076
- Bordeaux University Hospital - CRB medical office - Hôpital du Tondu
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Bordeaux、フランス、33076
- Bordeaux University Hospital - Service UDH - Hôpital Pellegrin
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Brive-la-Gaillarde、フランス、19100
- CABCL Rugby Training Center
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Bègles、フランス、33130
- Union Bordeaux-Bègles training center
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Carcassonne、フランス、11000
- US Carcassonne Rugby training center
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Colomiers、フランス、31770
- Union Sportive Colomiers Rugby training center
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Grenoble、フランス、38100
- FC Grenoble Rugby training center
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La Rochelle、フランス、17000
- Stade Rochelais Rugby training center
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Le Plessis-Robinson、フランス、92350
- Racing92 training center
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Montauban、フランス、82000
- AS Montauban Rugby training center
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Nevers、フランス、58000
- US Nevers Rugby training center
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Paris、フランス、75016
- Stade Français training center
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Pau、フランス、64000
- Section Paloise Rugby training center
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Perpignan、フランス、66000
- USAP Training Center
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Romans-sur-Isère、フランス、26100
- Training center Valence Romans Drôme Rugby
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Saix、フランス、81710
- Castres Olympique training center
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Toulouse、フランス、31200
- Stade Toulousain Rugby training center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Minor,
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：High-level athletes
High level athletes are rugby players, intervention unit agents of the National Police, sports students. Definition of a COVID-19 positive subject : Any subject whose serology is positive (IgM and/or IgG) and/or the Reverse Transcription Polymerase Chain Reaction (RT-PCR) result is positive and/or the questionnaire is positive and/or a new electrocardiogram (ECG) abnormality. The COVID-19 negative subjects do not meet the definition of COVID-19 positive subjects. |
An ECG at rest is performed for all participants at Day 0. A centralized reading is performed by one of the 6 expert cardiologists participating in the research.
In case of positive COVID-19 serology and/or positive COVID-19 RT-PCR and/or new ECG abnormality and/or positive questionnaire, a stress test is performed.
In case of positive COVID-19 serology and/or positive COVID-19 RT-PCR and/or new ECG abnormality and/or positive questionnaire, a Cardiac echocardiography is performed.
In case of positive COVID-19 serology and/or positive COVID-19 RT-PCR and/or new ECG abnormality and/or positive questionnaire, a Cardiac rhythm monitoring is performed.
To determine the rhythmic risk of athletes
High resolution MRIs is performed on 200 athletes :
For all athletes included at the D0 inclusion visit, a centralized COVID-19 serology is performed to search for biomarkers associated with the occurrence of myocardial fibrosis: analysis of genetic determinants in relation to cardiac damage. For athletes who have performed MRI: Search for biomarkers associated with the occurrence of myocardial fibrosis: analyses of low-grade inflammation markers (cytokine assay and fibrosis markers). |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Presence of rhythmic risk markers bye the questionnaire
時間枠：Day 0
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Questionnaire looking for heart palpitations, chest pain/pressure and shortness of breath.
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Day 0
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Evaluation by resting ECG of rhythmic risk marker : repolarization disorders
時間枠：Day 0
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Presence or absence of repolarization disorders
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Day 0
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Evaluation by resting ECG of rhythmic risk marker : inverted T waves
時間枠：Day 0
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Presence or absence of inverted T waves
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Day 0
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Evaluation by resting ECG of rhythmic risk marker : ST segment abnormalities
時間枠：Day 0
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Presence or absence of ST segment abnormalities
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Day 0
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Evaluation by resting ECG of rhythmic risk marker : QRS fragmentation
時間枠：Day 0
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Presence or absence of QRS fragmentation
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Day 0
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Evaluation by resting ECG of rhythmic risk marker : ventricular extrasystoles (VES)
時間枠：Day 0
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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)
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Day 0
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Evaluation by resting ECG of rhythmic risk marker : ventricular tachycardia (VT)
時間枠：Day 0
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Presence or absence of VT.
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Day 0
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Presence of rhythmic risk markers bye the stress test
時間枠：Day 0
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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.
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Day 0
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Presence of rhythmic risk markers bye ECG holter
時間枠：Day 0
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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.
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Day 0
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Presence of rhythmic risk markers bye ECG monitoring during games and trainings
時間枠：Day 0
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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.
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Day 0
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Presence of rhythmic risk markers by pharmacological tests and/or electrophysiological exploration
時間枠：Day 0
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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.
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Day 0
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Presence of myocardial fibrosis by injected MRI
時間枠：Month 3
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In order to compare the prevalence of myocardial fibrosis between COVID-19 positive and COVID-19 negative individuals in high level athletes with or without rhythmic risk, a high resolution MRI is performed.
The examinations is performed on 1.5 or 3T MRI systems equipped with specific antennas for cardiology.
The sequence used to detect occult scars is a late enhancement sequence performed at least 15 minutes after injection of gadolinium salts, using a free-breathing 3D method, for a minimum spatial resolution of 2.5x1.25x1.25mm.
The images are reviewed by a core lab at the Bordeaux University Hospital.
The presence or absence of myocardial fibrosis is evaluated.
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Month 3
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Presence of transmural localization of myocardial fibrosis by injected MRI
時間枠：Month 3
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In order to compare the prevalence of myocardial fibrosis between COVID-19 positive and COVID-19 negative individuals in high level athletes with or without rhythmic risk, a high resolution MRI is performed.
The examinations is performed on 1.5 or 3T MRI systems equipped with specific antennas for cardiology.
The sequence used to detect occult scars is a late enhancement sequence performed at least 15 minutes after injection of gadolinium salts, using a free-breathing 3D method, for a minimum spatial resolution of 2.5x1.25x1.25mm.
The images are reviewed by a core lab at the Bordeaux University Hospital.
The presence or absence of transmural localization is evaluated.
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Month 3
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Measurement of cardiac scar size by injected MRI
時間枠：Month 3
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In order to compare the prevalence of myocardial fibrosis between COVID-19 positive and COVID-19 negative individuals in high level athletes with or without rhythmic risk, a high resolution MRI is performed.
The examinations is performed on 1.5 or 3T MRI systems equipped with specific antennas for cardiology.
The sequence used to detect occult scars is a late enhancement sequence performed at least 15 minutes after injection of gadolinium salts, using a free-breathing 3D method, for a minimum spatial resolution of 2.5x1.25x1.25mm.
The images are reviewed by a core lab at the Bordeaux University Hospital.
The size of scars is measured in milliliters (mL).
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Month 3
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Search for constitutional genetic biomarkers
時間枠：Month 5
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identification by sequencing of genetic variants that could have an impact on the occurrence of a severe form in individuals infected with SARS-CoV-2.
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Month 5
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Research of inflammation markers
時間枠：Month 5
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Th1/Th2/activation/inflammation/apoptosis markers are measured in sera by a Luminex test allowing the detection of 10 analytes with a commercial kit according to the manufacturer's instructions
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Month 5
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協力者と研究者
捜査官
- スタディチェア：Antoine BENARD, MD、University Hospital, Bordeaux
- 主任研究者：Laurent Chevalier, MD、Medical Center of the Bordeaux-Mérignac Sports Clinic
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CHUBX 2020/16
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。