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临床试验/NCT05768698
NCT05768698招募中不适用

Valutazione Delle Pressioni di Riempimento Del Ventricolo Sinistro Attraverso l'Impiego di un Software di Intelligenza Artificiale Applicato Alla Stima Dello Strain Atriale Sinistro Con Ecocardiografia Speckletracking: Studio di Validazione Mediante Cateterismo Cardiaco

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Left ventricular filling pressure

研究概览

简要总结

The goal of this single-center, prospective, observational study is to validate a software package based on an artificial intelligence algorithm for automated non-invasive estimation of LVFP against invasively measured ones by left and right heart catheterization; In addition, the added value of this new automated software to detect increased LVEDP > 15 mm Hg compared to the current ASE/EACVI algorithm for assessing diastolic dysfunction and longitudinal left atrial strain during the reservoir phase will be evaluated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Signed informed consent to be part of this study,
  • No pregnancy,
  • Good acoustic window and patient cooperation to obtain good 2- and 3-dimensional datasets focused on left atrium (LA),

排除标准

  • Unwillingness to be part of the study,
  • Patients with poor 2-dimensional imaging quality in ≥ 1 LA segment or lacking of a discernible R-R interval, which might preclude accurate strain measurements,
  • Patients with more than mild mitral valve heart disease, aortic regurgitation, left side valvular prosthesis or mitral valve repair, mitral annulus calcification (≥ 5 mm),
  • Patients with history or presence of atrial fibrillation (AF), supraventricular arrhythmias, ventricular paced rhythm, left bundle branch block (LBBB),
  • Patients taking diuretics or vasodilators (nitrates) on the day of the examination, which could alter loading conditions.

结局指标

主要结局

Left ventricular filling pressure

时间窗: During procedure

Invasively measured left ventricular filling pressure by right heart catheterization

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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