Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-06 @ 2:56 PM
Study NCT ID:
NCT02380534
Status:
WITHDRAWN
Last Update Posted:
2022-05-26
First Post:
2015-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Apheretic Technologies in Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding missing', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'lastUpdateSubmitDate': '2022-05-21', 'studyFirstSubmitDate': '2015-02-23', 'studyFirstSubmitQcDate': '2015-02-27', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lipid profile', 'timeFrame': '1 year', 'description': 'We will evaluate the efficacy of apheretic technique through the reduction of total cholesterol, LDL and HDL cholesterol, and triglycerides in the plasma sample expressed by mg/dL.'}], 'primaryOutcomes': [{'measure': 'Lp(a) reduction', 'timeFrame': '1 year', 'description': 'We will evaluate the efficacy of apheretic technique through the reduction of Lp(a) in the plasma sample expressed by mg/dL.'}], 'secondaryOutcomes': [{'measure': 'Inflammatory adypocytokines', 'timeFrame': '1 year', 'description': 'We will evaluate the efficacy of apheretic technique through the improvement of inflammatory adypocytokines in the plasma sample.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['High level of Lp(a)'], 'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'To evaluate the effects of H.E.L.P. apheresis on lipid profile, Lp(a) level, and some inflammatory adypocytokines in patients with high cardiovascular risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high Lp(a) not responsive to diet and pharmacological treatment\n\nExclusion Criteria:\n\n* heart failure\n* hepatic failure\n* renal failure'}, 'identificationModule': {'nctId': 'NCT02380534', 'briefTitle': 'Use of Apheretic Technologies in Cardiovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'Use of H.E.L.P. Apheresis in Patients With High Cardiovascular Disease Lp(a)-Related', 'orgStudyIdInfo': {'id': 'P-20140023880'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'active procedure', 'description': 'High cardiovascular risk patients will undergo H.E.L.P. apheresis.', 'interventionNames': ['Procedure: H.E.L.P. apheresis']}], 'interventions': [{'name': 'H.E.L.P. apheresis', 'type': 'PROCEDURE', 'description': 'High cardiovascular risk patients will undergo H.E.L.P. apheresis procedure every 3 weeks for 1 year.', 'armGroupLabels': ['active procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'IRCCS Policlinico S. Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Giuseppe Derosa', 'investigatorAffiliation': 'University of Pavia'}}}}