Evaluation of Pulmonary Doppler Signals in Patients With Systemic Sclerosis(SSc)

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Lung Doppler Signals (LDS) in Detecting Pulmonary Arterial Hypertension in Patients With Systemic Sclerosis (SSc)

Conditions
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Systemic Sclerosis, Pulmonary Hypertension

Intervention / Treatment
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* Radiation: Doppler ultrasound
* Device: Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 ≥ 9. 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doppler ultrasound<br>Recording Doppler ultrasound noninvasively from the right chest wall | Radiation: Doppler ultrasound<br>* Recording Doppler ultrasound noninvasively from the right chest wall<br>Device: Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC. | 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. | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Sclerosis, Pulmonary hypertension, Lung Doppler Signals