Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

Launched by UNIVERSITY OF MIAMI · Oct 24, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Sirolimus on cerebral aneurysms, which are bulges in the blood vessels in the brain that can be dangerous if they rupture. The goal is to see how Sirolimus may change the molecular characteristics of these aneurysms, potentially leading to better treatments in the future. The trial is currently looking for participants who are between 18 and 74 years old and are scheduled to undergo surgery for an unruptured cerebral aneurysm at Jackson Memorial Hospital.

To be eligible for the study, participants must be able to give informed consent and have no serious health issues that might interfere with the trial, such as certain cancers or severe kidney or liver problems. If you decide to participate, you will receive either Sirolimus or a placebo (a non-active substance) during your treatment. This trial is an important step in understanding how to better manage cerebral aneurysms and improve patient outcomes.

Gender

ALL

Eligibility criteria

• 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.