Athlete's Heart or Arrhythmogenic Right Ventricular Cardiomyopathy: Contribution of Exercise Cardiovascular Magnetic Resonance (CMR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evolution of right ventricular ejection fraction (RVEF) assessed with CMR during exercise
研究概览
简要总结
Prospective, nonrandomized, single-center, comparative study to define if right ventricular (RV) contractile reserve assessed by exercise CMR helps to improve the differential diagnosis between pathological and physiological remodeling of the RV; ie. arrhythmogenic right ventricular cardiomyopathy (ARVC) and athlete's heart.
详细描述
Comparison of the RV contractile reserve in 4 groups of patients: Arrhythmogenic right ventricular cardiomyopathy (ARVC) patients; endurance athletes with a dilated RV, endurance athletes with normal RV, untrained subject with normal RV.
Patients will come to the hospital for 3 visits (3 half days):
- Visit 1: clinical evaluation, rest ECG, rest echocardiography, cardio-pulmonary exercise test.
- Visit 2: exercise echocardiography, holter ECG monitor (48 yours)
- Visit 3: rest CMR and exercise CMR (ergocycle)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
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
- •Men or women aged 18 years and older,
- •patients with confirmed ARVC, but with no major RV dysfunction (RVEF >40%)
- •endurance athletes with dilated RV
- •endurance athletes with non-dilated RV
- •untrained healthy subjects with non-dilated RV
- •who signed a written free and informed consent:
排除标准
- •Patients with other cardiovascular disease;
- •Contra-indication to CMR (in particular presence of a non-CMR compatible implantable cardiac defibrillator);
- •Patients with permanent supraventricular arrhythmia;
- •Patients unable to perform an exercise test on an ergocycle;
- •Person subject to legal protection (safeguard justice, trusteeship and guardianship) and persons deprived of liberty
研究组 & 干预措施
ARVC patients
干预措施: Cardiac exercises and tests (Other)
Endurance athletes with a dilated RV
干预措施: Cardiac exercises and tests (Other)
Endurance athletes with normal RV
干预措施: Cardiac exercises and tests (Other)
Untrained subject with normal RV
干预措施: Cardiac exercises and tests (Other)
结局指标
主要结局
Evolution of right ventricular ejection fraction (RVEF) assessed with CMR during exercise
时间窗: Through study completion, an average of 1 month
次要结局
- Evolution of Tricuspid annular plane systolic excursion (TAPSE) during exercise(Through study completion, an average of 1 month)
- Evolution of RV fractional area during exercise(Through study completion, an average of 1 month)
- Evolution of S' tricuspid wave during exercise(Through study completion, an average of 1 month)
- Evolution of free wall RV strain during exercise(Through study completion, an average of 1 month)