Evaluation of Lung Doppler Signals (LDS) in Detecting Pulmonary Arterial Hypertension in Patients With Systemic Sclerosis (SSc)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.
研究概览
简要总结
Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package- the Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS (Lung Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in detecting PAH in SSc patients will be assessed in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Able and willing to give signed informed consent prior to enrollment
- •Male or female, ≥ 18 years of age
- •Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den Hoogen 2013): Score ≥
- •Patients with RHC data available from measurement within 3 weeks prior to TPD assessment
- •No change in or initiation of PAH specific therapy between the last RHC and TPD
排除标准
- •People unable or unwilling to give informed consent.
- •PCWP or LVEDP > 15 mmHg
- •Any PH etiology outside Group 1 (Dana Point, 2008)
- •Pregnant women
- •Patients having severe chest wall deformity
结局指标
主要结局
Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.
时间窗: 12 month
Analyze Doppler data of 4 SSc groups (according to pulmonary hypertension severity) resulting in typical features. The features will be implemented in a pre-determined diagnostic algorithm that will determine the overall statistical success of the method in comparison to RHC data.
次要结局
未报告次要终点