Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT04141020
Status:
RECRUITING
Last Update Posted:
2025-03-17
First Post:
2019-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2019-10-24', 'studyFirstSubmitQcDate': '2019-10-24', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gene expression from control arteries.', 'timeFrame': 'Day 18', 'description': 'Change in gene expressions will be reported as fold change from control arteries: superficial temporal artery from the same patient and the intracerebral temporal lobe artery from a different patient. Genes to be evaluated are endothelial cell marker genes such as Cluster of Differentiation (CD) 34, CD31, Von Willebrand Factor (vWF), E-selectin, Vascular Endothelial (VE)-cadherin and Endothelial Nitric Oxide Synthase (eNOS) and pro-inflammatory-matrix remodeling proliferation genes such as Matrix Metallopeptidase (MMP)3 and MMP9, Vascular Cell Adhesion Molecule (VCAM)-1, Intercellular Adhesion Molecule (ICAM), Inducible Nitric Oxide Synthase (iNOS), Membrane Cofactor Protein (MCP) and Interleukin (IL)-1ß.'}, {'measure': 'Change in gene expression between blood samples.', 'timeFrame': 'Day 18', 'description': 'Change in gene expressions will be reported as fold change of intra-aneurysmal blood to peripheral blood from the same patient. Genes to be evaluated are endothelial cell marker genes (CD34, CD31, vWF, E-selectin, VE-cadherin, and eNOS) and pro-inflammatory-matrix remodeling proliferation genes (MMP3, MMP9, VCAM-1, ICAM, iNOS, MCP, and IL-1ß).'}, {'measure': 'Change in gene expression.', 'timeFrame': 'Day 18', 'description': 'Fold change of IL-2 expression and expression of endothelial cell marker genes (CD34, CD31, vWF, E-selectin, VE-cadherin, and eNOS) and pro-inflammatory-matrix remodeling proliferation genes (MMP3, MMP9, VCAM-1, ICAM, iNOS, MCP, and IL-1ß) will be evaluated between sirolimus treated to non-treated patients.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Aneurysm']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to explore the effects of Sirolimus on the underlying molecular alterations of cerebral aneurysms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Undergoing one of the following procedures at Jackson Memorial Hospital:\n\n * Clipping of an unruptured cerebral artery aneurysm\n * Endovascular treatment of unruptured cerebral aneurysms (including those receiving coiling)\n2. ≥ 18 years of age\n3. Willing and able to give informed consent\n\nExclusion Criteria:\n\n1\\) Subjects meeting any of the following criteria will be excluded:\n\n* Dissecting, traumatic, or mycotic brain aneurysm.\n* Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test.\n* Women who are breastfeeding.\n* Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol.\n* Patients with known Human Immunodeficiency Virus (HIV) infection or other known immunodeficiency.\n* Patient with renal or liver failure\n* Interstitial pneumonitis\n* History of lymphoma\n* History of skin cancer\n* Hypersensitivity to sirolimus\n* Severe or unstable concomitant condition disease or chronic condition, which in the opinion of the investigator could affect assessment of the safety or efficacy of study intervention.'}, 'identificationModule': {'nctId': 'NCT04141020', 'briefTitle': 'Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms', 'orgStudyIdInfo': {'id': '20190857'}, 'secondaryIdInfos': [{'id': '1R01NS111119-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01NS111119-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microsurgical Clipping Treated with Sirolimus', 'description': 'Participants undergoing standard of care microsurgical clipping of unruptured cerebral aneurysm will be treated with 2 mg Sirolimus daily for 14-18 consecutive days prior to surgery.', 'interventionNames': ['Procedure: Microsurgical clipping', 'Drug: Sirolimus']}, {'type': 'EXPERIMENTAL', 'label': 'Endovascular Treatment Treated with Sirolimus', 'description': 'Participants undergoing standard of care endovascular treatment of unruptured cerebral aneurysm procedure will be treated with 2 mg Sirolimus daily for 14-18 consecutive days prior to procedure.', 'interventionNames': ['Procedure: Endovascular treatment', 'Drug: Sirolimus']}], 'interventions': [{'name': 'Microsurgical clipping', 'type': 'PROCEDURE', 'description': 'Standard of care microsurgical clipping of an unruptured cerebral artery aneurysm.', 'armGroupLabels': ['Microsurgical Clipping Treated with Sirolimus']}, {'name': 'Endovascular treatment', 'type': 'PROCEDURE', 'description': 'Standard of care endovascular treatment of an unruptured cerebral artery aneurysm.', 'armGroupLabels': ['Endovascular Treatment Treated with Sirolimus']}, {'name': 'Sirolimus', 'type': 'DRUG', 'otherNames': ['Rapamune'], 'description': 'Daily oral Sirolimus 2 mg tablets, adjusted as necessary per treating physician.', 'armGroupLabels': ['Endovascular Treatment Treated with Sirolimus', 'Microsurgical Clipping Treated with Sirolimus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jayro Toledo, MD', 'role': 'CONTACT', 'email': 'j.toledo2@med.miami.edu', 'phone': '305-243-8044'}, {'name': 'Robert M Starke, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Jayro Toledo, MD', 'role': 'CONTACT', 'email': 'j.toledo2@med.miami.edu', 'phone': '305-243-8044'}], 'overallOfficials': [{'name': 'Robert M Starke, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Robert Starke', 'investigatorAffiliation': 'University of Miami'}}}}