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临床试验/NCT05138003
NCT05138003已完成不适用

Detection of Myocardial Inflammation in Cyclists After Strenuous Exercise: a Pilot Study Part 2

Jessa Hospital2 个研究点 分布在 2 个国家目标入组 19 人开始时间: 2021年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
2
主要终点
Myocardial inflammation will be evaluated by T1/T2 mapping cardiac MRI in cyclists after a strenuous exercise

研究概览

简要总结

The study will evaluate myocardial inflammation in cyclists after high intense and sustained exercise. Our hypothesis is that strenuous exercise in recreational cyclists may be associated with myocardial inflammation. Myocardial fibrosis in asymptomatic athletes is associated with life-threatening arrhythmic events and sudden death. Although myocarditis seems to be the most likely underlying cause, it remains unclear if strenuous and sustained physical exercise can cause myocardial inflammation with development of myocyte necrosis and possibly myocardial fibrosis in athletes.

Nineteen recreational cyclists performing "L'ETAPE DU TOUR (EDT) de France" a cycling ride (175 km, 3600 m of positive altitude difference) on July 4 2021 will be included in this study. Each participant will complete a detailed questionnaire detailing their training history. All participants will have exercise testing approximately 1 week before the EDT stage to set aerobic and anaerobic gas exchange thresholds, as well as VO2max.

In part 2 of the study cardiac MRI will be performed at rest before the EDT cycling ride completion. An ECG registration using a RootiRx will be realized during and up to 6 hours after the cycling ride. An echocardiography and cardiac MRI will be repeated in each cyclist between 3 and 6 hours after EDT cycling ride completion. A blood sample will be obtained at that time after the ride. This time point is chosen based on the highest troponin release that 3 to 6 hours post-exercise would allow a sufficient amount of time for inflammation to develop and be detectable, corresponding with the time when cardiac Troponin T is typically detectable and representing the liberation of enzymes from damaged myocytes.

Finally, a third cardiac MRI will be repeated 24 hours after start of the cycling ride to verify the evolution of possible inflammation over this time period.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Recreational cyclists performing the 'étape du tour (EDT) de France 2021 ride

排除标准

  • •presence of pre-existing cardiovascular or pulmonary diseases, hypertension, diabetes, peripheral vascular diseases, any inflammatory or auto-immune diseases, active SARS-CoV-2 infection and the intake of anti-inflammatory drugs.

研究组 & 干预措施

Recreational cyclists performing the 'étape du tour (EDT) de France 2021

Other

干预措施: cardiac MRI (Diagnostic Test)

Recreational cyclists performing the 'étape du tour (EDT) de France 2021

Other

干预措施: Echocardiography (Diagnostic Test)

Recreational cyclists performing the 'étape du tour (EDT) de France 2021

Other

干预措施: RootiRx for the ECG monitoring during the cycling ride (Diagnostic Test)

Recreational cyclists performing the 'étape du tour (EDT) de France 2021

Other

干预措施: Blood sample (Diagnostic Test)

结局指标

主要结局

Myocardial inflammation will be evaluated by T1/T2 mapping cardiac MRI in cyclists after a strenuous exercise

时间窗: 12 months after study

T1 and T2 relaxation time will be measured on cardiac MRI in cyclists before and 3 to 6 hours after a high intense and sustained exercise to assess exercise-induced myocardial inflammation

次要结局

未报告次要终点

研究者

发起方
Jessa Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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