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Sirolimus for Molecular Changes in Cerebral Aneurysms

This study is looking into how Sirolimus, an oral medication, affects the molecular changes in cerebral aneurysms (weak spots in blood vessels in the brain). You may be able to join if you are at least 18 years old and are having surgery (microsurgical clipping) or a procedure through your blood vessels (endovascular treatment) for an unruptured cerebral aneurysm at Jackson Memorial Hospital. The researchers will measure changes in gene expression (how genes are turned on or off) in arteries and blood samples to see if Sirolimus has an effect. The current status of this study is unclear, and it plans to enroll 80 participants.

Study design
This interventional study plans to enroll 80 participants. It is exploring the effects of Sirolimus alongside standard treatments for cerebral aneurysms.
What's involved
Participants will undergo either microsurgical clipping or endovascular treatment for their aneurysm. They will also take daily oral Sirolimus 2 mg tablets, with the dose adjusted as needed by their doctor.
Compensation
Not stated in the trial record.
Follow-up
Changes in gene expression will be measured at Day 18 after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04141020

Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

Recruiting
PHASE2Ages 18+InterventionalBasic science
University of Miami
~80 participants
Updated 2026-03-23 on ClinicalTrials.gov
What's tested:Microsurgical clippingEndovascular treatmentSirolimus

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in gene expression from control arteries.
Measured over Day 18
+2 more outcomes measured

Conditions

Cerebral Aneurysm

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NCT04141020

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Miami

    Miami, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Robert M Starke, M.D. · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Jayro Toledo, MD
[email protected]
305-243-8044
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in gene expression from control arteries.Day 18

    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.

  • Change in gene expression between blood samples.Day 18

    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).

  • Change in gene expression.Day 18

    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.