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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
Sponsor:
Information provided by (Responsible Party):
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; 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
Experimental: Doppler ultrasound Radiation: Doppler ultrasound
Recording Doppler ultrasound noninvasively from the right chest wall




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Israel
Reumatology department, Rambam medical center
Haifa, Israel
Sponsors and Collaborators
Echosense Ltd.
Investigators
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Principal Investigator: Alexsandra Balbir, Dr Rambam Health Care Campus

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Responsible Party: Echosense Ltd.
ClinicalTrials.gov Identifier: NCT02246348     History of Changes
Other Study ID Numbers: DOP22_2
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: August 2014
Keywords provided by Echosense Ltd.:
Systemic Sclerosis
Pulmonary hypertension
Lung Doppler signals
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases