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Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19 (ASCCOVID19)

2021년 6월 22일 업데이트: University Hospital, Bordeaux

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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

984

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 프랑스
      • Angoulême, 프랑스, 16000
        • Training center Soyaux Angoulême XV Rugby
      • Aurillac, 프랑스, 15000
        • Training Center Stade Aurillacois
      • Bayonne, 프랑스, 64104
        • Aviron Bayonnais Rugby Pro Training Center
      • Biarritz, 프랑스, 64200
        • Biarritz Olympique Pays Basque training center
      • Bordeaux, 프랑스, 33076
        • Bordeaux University Hospital - CRB medical office - Hôpital du Tondu
      • Bordeaux, 프랑스, 33076
        • Bordeaux University Hospital - Service UDH - Hôpital Pellegrin
      • Brive-la-Gaillarde, 프랑스, 19100
        • CABCL Rugby Training Center
      • Bègles, 프랑스, 33130
        • Union Bordeaux-Bègles training center
      • Carcassonne, 프랑스, 11000
        • US Carcassonne Rugby training center
      • Colomiers, 프랑스, 31770
        • Union Sportive Colomiers Rugby training center
      • Grenoble, 프랑스, 38100
        • FC Grenoble Rugby training center
      • La Rochelle, 프랑스, 17000
        • Stade Rochelais Rugby training center
      • Le Plessis-Robinson, 프랑스, 92350
        • Racing92 training center
      • Montauban, 프랑스, 82000
        • AS Montauban Rugby training center
      • Nevers, 프랑스, 58000
        • US Nevers Rugby training center
      • Paris, 프랑스, 75016
        • Stade Français training center
      • Pau, 프랑스, 64000
        • Section Paloise Rugby training center
      • Perpignan, 프랑스, 66000
        • USAP Training Center
      • Romans-sur-Isère, 프랑스, 26100
        • Training center Valence Romans Drôme Rugby
      • Saix, 프랑스, 81710
        • Castres Olympique training center
      • Toulouse, 프랑스, 31200
        • Stade Toulousain Rugby training center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
진단 검사: Resting electrocardiogram
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.
진단 검사: Stress test
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.
진단 검사: Cardiac echocardiography
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.
진단 검사: Cardiac rhythm monitoring
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.
다른: Questionnaire
To determine the rhythmic risk of athletes
장치: Injected Cardiac MRI

High resolution MRIs is performed on 200 athletes :

  • 100 athletes without rhythmic abnormalities (50 individuals with positive COVID-19 status and 50 individuals with negative COVID-19 status)
  • 100 athletes with rhythmic abnormalities (50 individuals with positive COVID-19 status and 50 individuals with negative COVID-19 status)
생물학적: Blood sampling for biobank

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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Presence of rhythmic risk markers bye the questionnaire
기간: Day 0
Questionnaire looking for heart palpitations, chest pain/pressure and shortness of breath.
Day 0
Evaluation by resting ECG of rhythmic risk marker : repolarization disorders
기간: Day 0
Presence or absence of repolarization disorders
Day 0
Evaluation by resting ECG of rhythmic risk marker : inverted T waves
기간: Day 0
Presence or absence of inverted T waves
Day 0
Evaluation by resting ECG of rhythmic risk marker : ST segment abnormalities
기간: Day 0
Presence or absence of ST segment abnormalities
Day 0
Evaluation by resting ECG of rhythmic risk marker : QRS fragmentation
기간: Day 0
Presence or absence of QRS fragmentation
Day 0
Evaluation by resting ECG of rhythmic risk marker : ventricular extrasystoles (VES)
기간: 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)
Day 0
Evaluation by resting ECG of rhythmic risk marker : ventricular tachycardia (VT)
기간: Day 0
Presence or absence of VT.
Day 0
Presence of rhythmic risk markers bye the stress test
기간: 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.
Day 0
Presence of rhythmic risk markers bye ECG holter
기간: 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.
Day 0
Presence of rhythmic risk markers bye ECG monitoring during games and trainings
기간: 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.
Day 0
Presence of rhythmic risk markers by pharmacological tests and/or electrophysiological exploration
기간: 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.
Day 0

2차 결과 측정

결과 측정
측정값 설명
기간
Presence of myocardial fibrosis by injected MRI
기간: Month 3
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.
Month 3
Presence of transmural localization of myocardial fibrosis by injected MRI
기간: Month 3
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.
Month 3
Measurement of cardiac scar size by injected MRI
기간: Month 3
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).
Month 3
Search for constitutional genetic biomarkers
기간: Month 5
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.
Month 5
Research of inflammation markers
기간: Month 5
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
Month 5

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University Hospital, Bordeaux

수사관

  • 연구 의자: Antoine Bénard, MD, University Hospital, Bordeaux
  • 수석 연구원: Laurent Chevalier, MD, Medical Center of the Bordeaux-Mérignac Sports Clinic

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 6월 18일

기본 완료 (실제)

2021년 3월 2일

연구 완료 (실제)

2021년 3월 2일

연구 등록 날짜

최초 제출

2021년 6월 2일

QC 기준을 충족하는 최초 제출

2021년 6월 22일

처음 게시됨 (실제)

2021년 6월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 6월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 6월 22일

마지막으로 확인됨

2021년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CHUBX 2020/16

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

코로나바이러스감염증-19 : 코로나19에 대한 임상 시험

Resting electrocardiogram에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Panama

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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