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临床试验/NCT05772091
NCT05772091招募中不适用

Valeur Pronostique Dans Une Population d'Amylose Cardiaque Des paramètres échocardiographiques basée Sur Une Approche d'Apprentissage Automatique

Pr. Nicolas GIRERD4 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
4
主要终点
Rate of hospitalisation for acute heart failure

研究概览

简要总结

Transthyretin cardiac amyloidosis is an increasingly recognized cause of heart failure with preserved ejection fraction. Its diagnosis is currently based on a non-invasive method including biology and imaging. Still currently incurable, the evolution of this pathology is burdened by numerous comorbidities, including iterative hospitalizations for heart failure leading to death. The Machine Learning approach has already shown its efficiency in terms of diagnosis but its prognostic approach has not yet been studied.

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

入选标准

  • Patients with suspicion of transthyretin cardiac amyloidosis
  • Age ≥18 years

排除标准

  • Lack of data to confirm or overturn the transthyretin amyloidosis diagnostic
  • Echocardiographic data not allowing deep analysis (technical default, bad echogenicity of the patient)
  • Final diagnostic of AL or AA amyloidosis

结局指标

主要结局

Rate of hospitalisation for acute heart failure

时间窗: Minimum 1-year follow-up and until last news available

composite endpoint: rate of death from all causes and hospitalisation for acute heart failure following inclusion (with outcome 1)

Rate of death from all causes

时间窗: Minimum 1-year follow-up and until last news available

composite endpoint: rate of death from all causes and hospitalisation for acute heart failure following inclusion (with outcome 2

次要结局

  • Implantation of pacemaker/defibrillator during study(Minimum 1-year follow-up and until last news available)
  • Rate of death from all causes and hospitalisation for acute heart failure(Minimum 1-year follow-up and until last news available)
  • Rate of hospitalisation for acute heart failure(Minimum 1-year follow-up and until last news available)
  • Rate of death from all causes(Minimum 1-year follow-up and until last news available)
  • Rate of hospitalisation for acute heart failure (including repeated hospitalisation)(Minimum 1-year follow-up and until last news available)

研究者

发起方
Pr. Nicolas GIRERD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pr. Nicolas GIRERD

Professor

Central Hospital, Nancy, France

研究点 (4)

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