Phénogroupage basé Sur l'Apprentissage Automatique Dans la Cardiomyopathie Hypertrophique Pour Identifier Les Facteurs prédictifs de la Fibrose Myocardique et Les événements Cardiovasculaires
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 870
- 试验地点
- 2
- 主要终点
- Cardiovascular mortality (composite)
研究概览
简要总结
Hypertrophic cardiomyopathy is a pathology with a highly variable course, ranging from patients who are asymptomatic throughout their lives to those who experience sudden death and/or terminal heart failure.
The main objective is to develop and validate an algorithm (constructed through supervised learning) using cardiac imaging data to predict the risk of cardiovascular events in sarcomeric hypertrophic cardiomyopathy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed sarcomeric hypertrophic cardiomyopathy
排除标准
- •Echocardiographic data not allowing deep analysis (technical default, bad echogenicity of the patient)
- •Other causes of left ventricular hypertrophy that may hamper the diagnosis (p.e. aortic or sub-aortic stenosis, severe renal insufficiency, hypertension).
- •History of ischemic heart disease or associated myocarditis
- •Opposition of the patient to the use of his/her data
结局指标
主要结局
Cardiovascular mortality (composite)
时间窗: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Rates of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 2,3,4,5,6)
Hospitalisation for cardiovascular event (composite)
时间窗: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Rates of cardiovascular mortality, hospitalization for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1,3,4,5,6)
Onset of ventricular arrhythmia (composite)
时间窗: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1, 2,3, 5,6)
Onset of supra ventricular arrhythmia (composite)
时间窗: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1, 2,3,4,6)
Worsening of NYHA stage (composite)
时间窗: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1,2,4,5,6)
Onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (composite)
时间窗: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1,2,3,4,5)
次要结局
- Onset of tachycardia and or atrial fibrillation(From date of start of follow-up until death or loss to follow-up (up to 12 years of FU))
- Cardiac decompensation requiring IV diuretics intake(From date of start of follow-up until death or loss to follow-up (up to 12 years of FU))
- Sudden death, recovered or not recovered(From date of start of follow-up until death or loss to follow-up (up to 12 years of FU))
- Occurrence of atrial fibrillation, atrial tachycardia or atrial flutter(From date of start of follow-up until death or loss to follow-up (up to 12 years of FU))
- Cardiac remodelling(From date of start of follow-up until death or loss to follow-up (up to 12 years of FU))
研究者
Pr. Nicolas GIRERD
Clinical Professor
Central Hospital, Nancy, France