NIPRESS: Non-Invasive and Invasive Pressure Evaluation and Stratification Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 623
- 试验地点
- 1
- 主要终点
- Accuracy of non-invasive and invasive parameters for identifying elevated left ventricular filling pressure
研究概览
简要总结
This study evaluates how different non-invasive and invasive measurements reflect left ventricular filling pressure, an important indicator of cardiac function. Elevated filling pressure is associated with symptoms such as shortness of breath and plays a central role in the diagnosis and management of heart failure and pulmonary hypertension.
In clinical practice, filling pressure can be estimated using echocardiography or measured during cardiac catheterisation. However, the relationships between these measurements and their ability to accurately reflect true filling pressure are not fully understood.
This retrospective study includes patients who underwent cardiac catheterisation with invasive haemodynamic assessment and temporally related echocardiographic evaluation as part of routine clinical care. The aim is to improve understanding of how different measurements relate to each other and to identify which parameters best reflect elevated filling pressure.
The results are expected to support more accurate interpretation of haemodynamic measurements and improve clinical decision-making, particularly regarding the use of non-invasive versus invasive assessment.
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
- •Adult patients (≥18 years)
- •Clinically indicated left- and right-heart catheterisation under resting conditions
- •Availability of invasive left ventricular end-diastolic pressure (LVEDP) measurement
- •Availability of pulmonary capillary wedge pressure (PCWP) measurement
- •Availability of transthoracic echocardiography within 5 days of cardiac catheterisation
- •Adequate echocardiographic image quality for analysis
排除标准
- •Missing or incomplete invasive haemodynamic measurements (LVEDP or PCWP)
- •Missing or non-interpretable echocardiographic data
- •Haemodynamic instability at the time of measurement
- •Incomplete data required for analysis
结局指标
主要结局
Accuracy of non-invasive and invasive parameters for identifying elevated left ventricular filling pressure
时间窗: At the time of cardiac catheterisation (baseline)
Assessment of the ability of non-invasive and invasive surrogate parameters to identify elevated left ventricular filling pressure, with simultaneously obtained invasive left ventricular end-diastolic pressure serving as the reference standard
次要结局
未报告次要终点