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

Not Applicable

Withdrawn

• Conditions: Systemic Sclerosis; Pulmonary Hypertension
• Interventions: Radiation: Doppler ultrasound; Device: Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel)

• Registration Number: NCT02278445
• Lead Sponsor: Echosense Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-08
• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-10-30
• Study Start: 2014-11
• Primary Completion: 2015-11
• Last Update Submitted: 2015-11-29
• Study Completion: 2015-12
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Able and willing to give signed informed consent prior to enrollment
2. Male or female, ≥ 18 years of age
3. Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den Hoogen 2013): Score ≥ 9.
4. Patients with RHC data available from measurement within 3 weeks prior to TPD assessment
5. No change in or initiation of PAH specific therapy between the last RHC and TPD

Exclusion Criteria

1. People unable or unwilling to give informed consent.
2. PCWP or LVEDP > 15 mmHg
3. Any PH etiology outside Group 1 (Dana Point, 2008)
4. Pregnant women
5. Patients having severe chest wall deformity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Doppler ultrasound	Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel)	Recording Doppler ultrasound noninvasively from the right chest wall
Doppler ultrasound	Doppler ultrasound	Recording Doppler ultrasound noninvasively from the right chest wall

Primary Outcome Measures

Name	Time	Method
Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.	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.

Trial Locations

Locations (1)

Sheba Medical Center, Pulmonology department; 🇮🇱 Ramat Gan, Israel