Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-27 @ 9:52 PM
Study NCT ID:
NCT02339961
Status:
WITHDRAWN
Last Update Posted:
2015-12-02
First Post:
2015-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Pulmonary Arterial Hypertension in Patients With Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}], 'ancestors': [{'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-29', 'studyFirstSubmitDate': '2015-01-13', 'studyFirstSubmitQcDate': '2015-01-15', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.', 'timeFrame': '12 month', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Systemic Sclerosis', 'Pulmonary hypertension', 'Lung Doppler Signals'], 'conditions': ['Systemic Sclerosis', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to give signed informed consent prior to enrollment\n2. Male or female, ≥ 18 years of age\n3. Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den Hoogen 2013): Score ≥ 9.\n4. Patients with RHC data available from measurement within 3 weeks prior to TPD assessment\n5. No change in or initiation of PAH specific therapy between the last RHC and TPD\n\nExclusion Criteria:\n\n1. People unable or unwilling to give informed consent.\n2. PCWP or LVEDP \\> 15 mmHg\n3. Any PH etiology outside Group 1 (Dana Point, 2008)\n4. Pregnant women\n5. Patients having severe chest wall deformity'}, 'identificationModule': {'nctId': 'NCT02339961', 'briefTitle': 'Evaluating Pulmonary Arterial Hypertension in Patients With Systemic Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Echosense Ltd.'}, 'officialTitle': 'Evaluation of Lung Doppler Signals (LDS) in Detecting Pulmonary Arterial Hypertension in Patients With Systemic Sclerosis (SSc)', 'orgStudyIdInfo': {'id': 'DOP22_4'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound radiation', 'type': 'RADIATION', 'description': 'Recording Doppler ultrasound noninvasively from the right chest wall'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sara Pel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reumatology institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Echosense Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}