Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)
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|ClinicalTrials.gov Identifier: NCT02246348|
Recruitment Status : Terminated (Low recruitment rate)
First Posted : September 22, 2014
Last Update Posted : January 21, 2016
Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package; i.e. 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 signals that are related to pulmonary hypertension.
The TPD performance in detecting PAH in SSc patients will be assessed in the study.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Sclerosis Pulmonary Hypertension||Radiation: Doppler ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Lung Doppler Signals (LDS) in Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc)|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||December 2015|
|Experimental: Doppler ultrasound||
Radiation: Doppler ultrasound
Recording Doppler ultrasound noninvasively from the right chest wall
- Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC. [ Time Frame: 12 month ]Analyze Doppler data of 4 SSc groups (according to pulmonary hypertension sevirity) resulting in typical features. The features will be implemented in a pre-determined diagnostic algorithm that will determine the overall statistical analysis success of the method in comparison to RHC data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246348
|Reumatology department, Rambam medical center|
|Principal Investigator:||Alexsandra Balbir, Dr||Rambam Health Care Campus|