Back to resultsEvaluation of Pulmonary Doppler Signals in Patients With Systemic Sclerosis(SSc)
Primary Purpose
Systemic Sclerosis, Pulmonary Hypertension
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Doppler ultrasound
Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel)
Sponsored by
About this trial
This is an interventional diagnostic trial for Systemic Sclerosis focused on measuring Systemic Sclerosis, Pulmonary hypertension, Lung Doppler Signals
Eligibility Criteria
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
Sites / Locations
- Sheba Medical Center, Pulmonology department
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Doppler ultrasound
Arm Description
Recording Doppler ultrasound noninvasively from the right chest wall
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02278445
Brief Title
Evaluation of Pulmonary Doppler Signals in Patients With Systemic Sclerosis(SSc)
Official Title
Evaluation of Lung Doppler Signals (LDS) in Detecting Pulmonary Arterial Hypertension in Patients With Systemic Sclerosis (SSc)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Withdrawn
Why Stopped
No patients
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Echosense Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis, Pulmonary Hypertension
Keywords
Systemic Sclerosis, Pulmonary hypertension, Lung Doppler Signals
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Doppler ultrasound
Arm Type
Experimental
Arm Description
Recording Doppler ultrasound noninvasively from the right chest wall
Intervention Type
Radiation
Intervention Name(s)
Doppler ultrasound
Intervention Description
Recording Doppler ultrasound noninvasively from the right chest wall
Intervention Type
Device
Intervention Name(s)
Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel)
Primary Outcome Measure Information:
Title
Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.
Description
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.
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merav Lidar, Dr
Organizational Affiliation
Sheba medical center, Rheumatology department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center, Pulmonology department
City
Ramat Gan
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Pulmonary Doppler Signals in Patients With Systemic Sclerosis(SSc)
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