Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

Phase 2RecruitingNCT04141020

University of Miami80 enrolled

Overview

The objective of this study is to explore the effects of Sirolimus on the underlying molecular alterations of cerebral aneurysms.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Cerebral Aneurysm

Interventions

Microsurgical clippingPROCEDURE

Standard of care microsurgical clipping of an unruptured cerebral artery aneurysm.

Endovascular treatmentPROCEDURE

Standard of care endovascular treatment of an unruptured cerebral artery aneurysm.

SirolimusDRUG

Daily oral Sirolimus 2 mg tablets, adjusted as necessary per treating physician.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Undergoing one of the following procedures at Jackson Memorial Hospital: * Clipping of an unruptured cerebral artery aneurysm * Endovascular treatment of unruptured cerebral aneurysms (including those receiving coiling) 2. ≥ 18 years of age 3. Willing and able to give informed consent Exclusion Criteria: 1\) Subjects meeting any of the following criteria will be excluded: * Dissecting, traumatic, or mycotic brain aneurysm. * Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test. * Women who are breastfeeding. * Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol. * Patients with known Human Immunodeficiency Virus (HIV) infection or other known immunodeficiency. * Patient with renal or liver failure * Interstitial pneumonitis * History of lymphoma * History of skin cancer * Hypersensitivity to sirolimus * 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.

Locations (1)

University of Miami

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Change in gene expression from control arteries.

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.

Time frame: Day 18

Change in gene expression between blood samples.

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).

Time frame: Day 18

Change in gene expression.

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.

Time frame: Day 18

Central Contacts

Jayro Toledo, MD

CONTACT

305-243-8044 j.toledo2@med.miami.edu

Data from ClinicalTrials.gov

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