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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 February 2016 |
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Main ID: |
NCT02246348 |
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Date of registration:
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17/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)
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Scientific title:
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Evaluation of Lung Doppler Signals (LDS) in Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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5 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02246348 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Alexsandra Balbir, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rambam Health Care Campus |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Hypertension
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Systemic Sclerosis
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Intervention(s)
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Radiation: Doppler ultrasound
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Primary Outcome(s)
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Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.
[Time Frame: 12 month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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