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NCT Number: NCT04141020

Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

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

Recruiting

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Key information

Conditions

Cerebral Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Jayro Toledo, MD

CONTACT

[email protected]

305-243-8044

Robert M Starke, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • ≥ 18 years of age
  • Willing and able to give informed consent

Exclusion criteria

  • 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.

Treatment and study plan

Microsurgical clipping

Procedure

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

endovascular treatment

Procedure

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.

Other names: Rapamune

Primary outcomes

  1. Change in gene expression from control arteries.

    Time frame: 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.

  2. Change in gene expression between blood samples.

    Time frame: 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).

  3. Change in gene expression.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jayro Toledo, MD

CONTACT

[email protected]

305-243-8044

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 28, 2019
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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