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Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

ConditionCerebral Aneurysm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clipping of an unruptured cerebral artery aneurysm

Endovascular treatment of unruptured cerebral aneurysms (including those receiving coiling)

≥ 18 years of age

Willing and able to give informed consent

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Microsurgical clipping

    Procedure/Surgery

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

  • Endovascular treatment

    Procedure/Surgery

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

  • Sirolimus

    Drug

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Microsurgical Clipping Treated with SirolimusExperimental treatment 2 interventions
Group B: Endovascular Treatment Treated with SirolimusExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov
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