Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-01 @ 11:06 PM
Study NCT ID:
NCT03245957
Status:
UNKNOWN
Last Update Posted:
2019-03-07
First Post:
2017-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HDL Dysfunction During the Acute Stage of Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-06', 'studyFirstSubmitDate': '2017-08-08', 'studyFirstSubmitQcDate': '2017-08-08', 'lastUpdatePostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'HDL dysfunction', 'timeFrame': 'Through study completion, an average of 6 hours', 'description': 'Assessment of HDL function using inhibition test on cell culture'}], 'primaryOutcomes': [{'measure': 'Plasma MPO concentrations', 'timeFrame': 'Through study completion, an average of 6 hours', 'description': 'Assessment of plasma MPO concentrations during acute stage of stroke'}], 'secondaryOutcomes': [{'measure': 'HDL-MPO concentrations', 'timeFrame': 'Through study completion, an average of 6 hours', 'description': 'Assessment of HDL-MPO concentrations during acute stage of stroke'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Acute']}, 'descriptionModule': {'briefSummary': 'The study investigates the effect of plasma myeloperoxidase (MPO) concentrations on HDL dysfunction during the acute stage of ischemic and haemorrhagic strokes.', 'detailedDescription': 'MRI or CT scan are used to confirm the diagnosis of haemorrhagic, ischemic and mimick stroke.\n\nPlasma anf HDL-MPO concentrations, as well as potent HDL dysfunction, are compared in the 3 cases.\n\nThe investigators hypothesis is that MPO concentrations and subsequent HDL dysfunction could be higher in ischemic strokes than in haemorrhagic ones. MPO could be a examined as a potent marker of early stage of ischemic stroke.\n\nPlasma MPO levels could also be discriminant regarding the mimick strokes in patient exhibiting stroke clinical picture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with clinical picture of early stage of stroke with the first signed lasting for less than 12 hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with less than 12 hours stroke clinical signs:\n\n* hemiparesis or hemiplegia\n* unilateral sensitivity disorder\n* language impairment\n* balance disorder\n* dizziness, bilateral or monocular vision totally or partially lost\n\nExclusion Criteria:\n\n* Pregnancy\n* head trauma since the last 3 months\n* stroke since the last 3 months\n* myocardial infarction since the last 3 months\n* patient disagrees to be enrolled in the study'}, 'identificationModule': {'nctId': 'NCT03245957', 'acronym': 'RUSH', 'briefTitle': 'HDL Dysfunction During the Acute Stage of Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'HDL Dysfunction During the Acute Stage of Stroke', 'orgStudyIdInfo': {'id': '2016/CHU/06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ischemic stroke', 'description': 'Patients with ischemic stroke diagnosed by MRI or CT scan', 'interventionNames': ['Other: Ischemic stroke']}, {'label': 'Haemorrhagic stroke', 'description': 'Patients without haemorrhagic stroke diagnosed by MRI or CT scan', 'interventionNames': ['Other: Haemorrhagic stroke']}, {'label': 'Mimick stroke', 'description': 'Patients without haemorrhagic or ischemic stroke diagnosed by MRI or CT scan'}], 'interventions': [{'name': 'Ischemic stroke', 'type': 'OTHER', 'description': 'Patients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan', 'armGroupLabels': ['Ischemic stroke']}, {'name': 'Haemorrhagic stroke', 'type': 'OTHER', 'description': 'Patients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan', 'armGroupLabels': ['Haemorrhagic stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97410', 'city': 'Saint-Pierre', 'state': 'Reunion Island', 'status': 'RECRUITING', 'country': 'Reunion', 'contacts': [{'name': 'COURET DAVID, MD', 'role': 'CONTACT', 'email': 'david.couret@chu-reunion.fr', 'phone': '+262262359000'}], 'facility': 'Chu Reunion Island', 'geoPoint': {'lat': -21.3393, 'lon': 55.47811}}], 'centralContacts': [{'name': 'Christine JUHEL, PHD', 'role': 'CONTACT', 'email': 'christine.juhel@chu-reunion.fr', 'phone': '+262262359949'}, {'name': 'David COURET, MD', 'role': 'CONTACT', 'email': 'david.couret@chu-reunion.fr', 'phone': '+262262359000'}], 'overallOfficials': [{'name': 'David COURET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hpospitalier Universitaire de La REUNION'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}