Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT00822302
Status:
COMPLETED
Last Update Posted:
2015-06-09
First Post:
2009-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial to Evaluate the Ability of a Single Infusion of High-Density Lipoprotein (HDL) to Modulate Markers of Cerebral Ischaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053442', 'term': 'High-Density Lipoproteins, Pre-beta'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D008075', 'term': 'Lipoproteins, HDL'}, {'id': 'D008074', 'term': 'Lipoproteins'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-05', 'studyFirstSubmitDate': '2009-01-13', 'studyFirstSubmitQcDate': '2009-01-13', 'lastUpdatePostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammatory and thrombotic response', 'timeFrame': 'baseline, 24 hours after infusion, 48 hours after infusion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atherosclerosis', 'stroke', 'ischaemia'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The plasma concentration of high-density lipoprotein (HDL) can have anti-inflammatory, anti-oxidative and anti-thrombotic effects in addition to being able to remove cholesterol from peripheral tissues for secretion via the liver.\n\nThe investigators hypothesise that elevation of plasma HDLs will reduce the inflammatory response following removal of unstable atherosclerotic plaques in the carotid artery. Such plaques can cause strokes and there is great benefit from early surgical removal, however such surgical procedures involve significant risks to the patient.\n\nThe investigators propose infusing HDL into patients prior to removal of their unstable carotid plaque and measuring the changes in inflammatory responses in comparison to a similar placebo controlled group of patients.', 'detailedDescription': 'Following written informed consent, patients will be randomised to either the placebo or active arm of the study. Bloods will be taken for baseline measurements, and the infusion of either saline (placebo) or rHDL (active agent) will be carried out on the ward. Infusion will take 4 hours, and the active agent infused at 40mg/kg.\n\nJust prior to CAE, bloods will be collected (24 hours post-infusion) and the atherosclerotic tissue collected into RNA stabilising agent for subsequent analysis. Further bloods will then be collected 24 hours post-operatively (48 hours post-infusion).\n\nPatients vital signs will be monitored hourly following infusion and will be reviewed in out-patients at 6 weeks after the operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients listed for elective carotid endarterectomy\n\nExclusion Criteria:\n\n* pregnant women and women of childbearing age\n* patient with impaired renal function or liver function\n* patients sectioned under the Mental Health Act'}, 'identificationModule': {'nctId': 'NCT00822302', 'acronym': 'REVEAL', 'briefTitle': 'Trial to Evaluate the Ability of a Single Infusion of High-Density Lipoprotein (HDL) to Modulate Markers of Cerebral Ischaemia', 'organization': {'class': 'OTHER', 'fullName': "St George's, University of London"}, 'officialTitle': 'Does recHDL Given i.v. Before CEA Prevent Cerebral Ischaemia? - the Reveal Study.', 'orgStudyIdInfo': {'id': 'Eudract Nos: 2008-000093-21'}, 'secondaryIdInfos': [{'id': 'DTX/DDX number:MF8000/13329'}, {'id': 'Protocol Nos: 04.0008'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1.Saline Infusion', 'description': 'Patients randomised to this arm will receive an infusion of saline', 'interventionNames': ['Drug: Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2.recHDL', 'description': 'Patients randomised to the active comparator arm of the study will receive 40mg/kg reconstituted High density lipoproteins (lot nos 05422-00006) over a period of 4 hours, 24 hours prior to carotid endarterectomy.', 'interventionNames': ['Drug: Reconstituted High Density Lipoprotein']}], 'interventions': [{'name': 'Reconstituted High Density Lipoprotein', 'type': 'DRUG', 'otherNames': ['rHDL', 'discoidal HDL'], 'description': 'RecHDL (Lot Nos 05422-00006)is provided as a lyophilised powder and reconstituted with sterile water at 25 mg/ml. The infusion is made at 40 mg/kg over a period of 4 hours.', 'armGroupLabels': ['2.recHDL']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['normal saline'], 'description': 'Saline (0.9%) is provided as a sterile infusion bag and infused over a period of 4 hours, 24 hours prior to carotid endarterectomy', 'armGroupLabels': ['1.Saline Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW17 0QT', 'city': 'London', 'state': 'Tooting', 'country': 'United Kingdom', 'facility': 'St Georges University of London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St George's, University of London", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}