Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-28 @ 10:38 PM
Study NCT ID:
NCT01644656
Status:
COMPLETED
Last Update Posted:
2018-09-06
First Post:
2012-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-12-20', 'releaseDate': '2019-12-02'}], 'estimatedResultsFirstSubmitDate': '2019-12-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054459', 'term': 'Elasticity Imaging Techniques'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-04', 'studyFirstSubmitDate': '2012-06-19', 'studyFirstSubmitQcDate': '2012-07-16', 'lastUpdatePostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation of acoustic radiation force impulse (ARFI) measurement of organ stiffness with hepatic venous pressure gradient (HVPG)', 'timeFrame': 'Both outcome measurements (ARFI measurements and HVPG) will be obtained within an average time frame of 4-8 hours', 'description': 'Both measurements are estimates of portal hypertension (defined as equal to HVPG greater than 10 mmHg).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['portal hypertension', 'cirrhosis', 'ARFI', 'diagnostic study'], 'conditions': ['Portal Hypertension', 'Chronic Liver Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this diagnostic study is to evaluate the efficacy of ARFI imaging (a specific type of ultrasound) in assessing the pressure of the portal vein (the major vein passing through the liver) and the amount of liver fibrosis in patients with chronic liver disease.', 'detailedDescription': 'DESIGN The study is designed as a prospective, cross-sectional, diagnostic study in which the investigators will evaluate the use of ARFI to diagnose clinically significant portal hypertension (CSPH defined as hepatic veous pressure gradient (HVPG)greater than 10 mmHg), taking HVPG measurements as gold standard.\n\nMETHODOLOGY\n\n* The study will be performed at the VA Connecticut Healthcare System-West Haven and Yale.\n* Study population will be recruited among patients from the VA/Yale Liver Clinics or outside hospitals that are referred to VA/Yale for a transjugular liver biopsy and hepatic venous pressure gradient measurement as part of their routine care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-85 years\n* compensated chronic liver disease with suspected or confirmed liver cirrhosis sent for transjugular liver biopsy as part of their routine care\n* signed informed consent\n\nExclusion Criteria:\n\n* known contraindications to the performance of an HVPG measurement or a trans-jugular biopsy\n* portal thrombosis\n* previous surgical or transjugular portosystemic shunt\n* previous total or partial splenectomy\n* presence of comorbid conditions conferring a life expectancy of less than 1 year'}, 'identificationModule': {'nctId': 'NCT01644656', 'briefTitle': 'Non-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)', 'organization': {'class': 'FED', 'fullName': 'VA Connecticut Healthcare System'}, 'officialTitle': 'Non-invasive Diagnosis of Portal Hypertension by Acoustic Radiation Force Impulse (ARFI) Imaging of the Liver and Spleen in Patients With Chronic Liver Disease', 'orgStudyIdInfo': {'id': '01582'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'acoustic radiation force impulse (ARFI)', 'description': 'Imaging of liver and spleen using modified ultrasound', 'interventionNames': ['Device: ARFI ultrasound']}], 'interventions': [{'name': 'ARFI ultrasound', 'type': 'DEVICE', 'otherNames': ['acoustic radiation force impulse'], 'description': 'ARFI imaging of the liver and spleen will be performed immediately before transjugular liver biopsy and HVPG procedures', 'armGroupLabels': ['acoustic radiation force impulse (ARFI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale-New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Healthcare System', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'overallOfficials': [{'name': 'Guadalupe Garcia-Tsao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Connecticut Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Connecticut Healthcare System', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-12-02', 'type': 'RELEASE'}, {'date': '2019-12-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'VA Connecticut Healthcare System'}}}}