Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-03-11 @ 4:43 PM
Study NCT ID:
NCT05436860
Status:
UNKNOWN
Last Update Posted:
2023-12-05
First Post:
2022-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PreDEA Study, Prevention in Emergency / Acceptance Departments: the Case of Hepatic Steatosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20189}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2022-06-24', 'studyFirstSubmitQcDate': '2022-06-24', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the number of steatotic patients who access the emergency room - Emergency room as a tool for early diagnosis of hepatic steatosis', 'timeFrame': '12 months', 'description': 'Evaluation of the effectiveness of the Emergency Department as a screening tool for the emergence of the submerged by measuring the prevalence, on the national territory, of hepatic steatosis in patients who access the emergency room.'}], 'secondaryOutcomes': [{'measure': 'Develop new prognostic algorithms for assessing the risk of major and minor clinical events in patients with fatty liver.', 'timeFrame': '36 months', 'description': 'Improve the approval rating of the service offered by the PS to the patient who has been assigned a white or green color code for triage.To develop new prognostic algorithms for assessing the risk of major and minor clinical events in patients with fatty liver.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Steatosis']}, 'descriptionModule': {'briefSummary': 'Our study aims to evaluate whether the Emergency Department (PS) can support the health system to improve the prevention and management of chronic inflammatory diseases and ensure actions aimed at screening, raising awareness and informing the population.\n\nSpecifically, the determination of the prevalence of a widely diffused pathology such as fatty liver disease aims to be the precursor of future pilot studies aimed at evaluating the advantages and critical issues of the PS as a prevention tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to Emergency department ,over 18, in white or green code', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18\n* Patients admitted to Emergency department in white or green code\n\nExclusion Criteria:\n\n* Patients under 18\n* Patients admitted to Emergency department in yellow or red code'}, 'identificationModule': {'nctId': 'NCT05436860', 'briefTitle': 'PreDEA Study, Prevention in Emergency / Acceptance Departments: the Case of Hepatic Steatosis', 'organization': {'class': 'OTHER', 'fullName': "University of L'Aquila"}, 'officialTitle': 'Pre- Emergency / Acceptance Departments Study, Prevention in Emergency / Acceptance Departments: the Case of Hepatic Steatosis', 'orgStudyIdInfo': {'id': '61615'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'presence of hepatic hyperechogenicity on ultrasound evaluation', 'interventionNames': ['Device: liver ultrasound']}, {'label': 'absence of hepatic hyperechogenicity on ultrasound evaluation', 'interventionNames': ['Device: liver ultrasound']}], 'interventions': [{'name': 'liver ultrasound', 'type': 'DEVICE', 'description': 'At the time of access to the emergency room, a cohort of male and female patients aged 18 or over will be consecutively recruited with green or white color coded triage.\n\npatients who agree to participate in the study will undergo liver ultrasound. Patients who test negative on ultrasound evaluation for liver hyperechogenicity will be part of the control group.', 'armGroupLabels': ['absence of hepatic hyperechogenicity on ultrasound evaluation', 'presence of hepatic hyperechogenicity on ultrasound evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67100', 'city': 'L’Aquila', 'state': "Italy/L'Aquila", 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Clara Balsano', 'role': 'CONTACT', 'email': 'clara.balsano@univaq.it', 'phone': '+390862434774'}], 'facility': 'Clara Balsano', 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}], 'centralContacts': [{'name': 'Clara Balsano, MD', 'role': 'CONTACT', 'email': 'clara.balsano@univaq.it', 'phone': '+39 0862434774'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University of L'Aquila", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full professor', 'investigatorFullName': 'Clara Balsano', 'investigatorAffiliation': "University of L'Aquila"}}}}