Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-31 @ 11:58 AM
Study NCT ID:
NCT02397759
Status:
UNKNOWN
Last Update Posted:
2015-03-25
First Post:
2015-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolomic Profile and Proteasic Activity as Biomarkers for Early Detection of Arterial Vasospas in Arterial Vasospasm After Aneurysmal Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'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': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-20', 'studyFirstSubmitDate': '2015-03-20', 'studyFirstSubmitQcDate': '2015-03-20', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'biomarkers iendtification of vasospasm', 'timeFrame': '3 years', 'description': 'It will be identify biomarkers of vasospasm in blood and CSF without a priori assumption by metabolomics. Analysis will be by chromatography system coupled to a high resolution mass spectrometer'}], 'secondaryOutcomes': [{'measure': 'occurrence of vasopasm', 'timeFrame': '3 years', 'description': 'It will be study in the blood and CSF association between matrix metalloproteinases (MMP) 2 and 9 and the occurrence of vasopasm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Subarachnoid Hemorrhage (SAH) From Ruptured Aneurysm']}, 'referencesModule': {'references': [{'pmid': '38148664', 'type': 'DERIVED', 'citation': 'Chikh K, Tonon D, Triglia T, Lagier D, Buisson A, Alessi MC, Defoort C, Benatia S, Velly LJ, Bruder N, Martin JC. Early Metabolic Disruption and Predictive Biomarkers of Delayed-Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage. J Proteome Res. 2024 Jan 5;23(1):316-328. doi: 10.1021/acs.jproteome.3c00575. Epub 2023 Dec 26.'}, {'pmid': '27355865', 'type': 'DERIVED', 'citation': 'Triglia T, Mezzapesa A, Martin JC, Verdier M, Lagier D, Dufour H, Bruder N, Alessi MC, Velly LJ. Early matrix metalloproteinase-9 concentration in the first 48 h after aneurysmal subarachnoid haemorrhage predicts delayed cerebral ischaemia: An observational study. Eur J Anaesthesiol. 2016 Sep;33(9):662-9. doi: 10.1097/EJA.0000000000000494.'}]}, 'descriptionModule': {'briefSummary': 'The subarachnoid hemorrhage (SAH) from ruptured aneurysm is a situation that is life-threatening, which is largely dependent on the occurrence of vasospasm from the 4th day after the bleeding. This vasopasm is responsible of clinical morbidity in 30 to 50% of patients. It occurs in 40% of patients with severe SAH.\n\nDespite knowing this, the clinician has no biomarker for identifying patients at risk.\n\nThe project presented is original and includes a screening method without a priori to identify predictive biomarkers of vasospasm, likely to become therapeutic targets. In secondary objective we will focus on the protease activity of cerebrospinal fluid (CSF) and blood as a biomarker potential of vasoconstriction at the waning of subarachnoid hemorrhage.\n\nThis study will take place over a year prospectively. The inclusion of patients will be in the SAR 1 Hospital of Timone. Patients with severe severe SAH by rupture requiring the establishment of an external ventricular derivation (EVD) will be divided into two groups and compared to one group of patients without necessitating a EVD subarachnoid hemorrhage.\n\n* Group 1: Patients with vasopasm\n* Group 2: Patient presenting no vasopasm Detection of vasopasm was defined using a consensual definition. CSF samples (through EVD) and blood will be made upon arrival of the patient in intensive care and then between the 3rd and 4th day.\n\nAs the main criterion, we will identify biomarkers of vasospasm in blood and CSF without a priori assumption by metabolomics. Analysis will be by chromatography system coupled to a high resolution mass spectrometer. This method does not justify effective calculation because it is a step of generating hypotheses requiring further biological validation based on the identified targets.\n\nThe secondary criteria, we will study in the blood and CSF association between matrix metalloproteinases (MMP) 2 and 9 and the occurrence of vasopasm.\n\nRESULTS: After comparative analysis of groups 1 and 2 in two phases of the study, we will define a metabolic profile that could identify predictive biomarkers vasopasm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with severe severe SAH by rupture requiring the establishment of an external ventricular derivation (EVD) will be divided into two groups\n* Group 1: Patients with vasopasm\n* Group 2: Patient presenting no vasopasm\n\nExclusion Criteria:\n\n* Patients presenting an infectious or carcinologic meningitis'}, 'identificationModule': {'nctId': 'NCT02397759', 'briefTitle': 'Metabolomic Profile and Proteasic Activity as Biomarkers for Early Detection of Arterial Vasospas in Arterial Vasospasm After Aneurysmal Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Analysis of Cerebral Spinal Fluid and Plasma After Aneurysmal Subarachnoid Hemorrhage by Evaluating a Metabolomic Profile and the Proteasic Activity as Biomarkers for Early Detection of Arterial Vasospasm', 'orgStudyIdInfo': {'id': '2012-54'}, 'secondaryIdInfos': [{'id': '2013-A00184-41', 'type': 'REGISTRY', 'domain': 'Ansm'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with severe SAH and vasospasm', 'description': 'Patients with severe SAH from ruptured aneurysm requiring the establishment of an external ventricular derivation (EVD) and presenting vasospasm', 'interventionNames': ['Other: Blood draw and cerebrospinal fluid draw']}, {'type': 'EXPERIMENTAL', 'label': 'Patients with severe SAH without vasospasm', 'description': 'Patients with severe SAH from ruptured aneurysm requiring the establishment of an external ventricular derivation (EVD) without vasospasm', 'interventionNames': ['Other: Blood draw and cerebrospinal fluid draw']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with severe SAH without external ventricular derivati', 'description': 'Patients with severe severe SAH from ruptured aneurysm without necessitating a EVD subarachnoid hemorrhage', 'interventionNames': ['Other: Blood draw and cerebrospinal fluid draw']}], 'interventions': [{'name': 'Blood draw and cerebrospinal fluid draw', 'type': 'OTHER', 'armGroupLabels': ['Patients with severe SAH and vasospasm', 'Patients with severe SAH without external ventricular derivati', 'Patients with severe SAH without vasospasm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thibaut TRIGLIA, MD', 'role': 'CONTACT', 'email': 'thibaut.triglia@ap-hm.fr'}], 'facility': 'Hôpiital de la TIMONE ASSISTANCE PUBLIQUE HOPITAUX de MARSEILLE', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Thibaut TRIGLIA', 'role': 'CONTACT', 'email': 'thibaut.triglia@ap-hm.fr', 'phone': '+33491329460'}], 'overallOfficials': [{'name': 'Urielle DESALBRES', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}