Effects of Sirolimus on Cerebral Aneurysms
Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
This study is testing if the medication Sirolimus can change the biology of unruptured cerebral aneurysms in people undergoing surgery or treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT04141020 on ClinicalTrials.gov |
What this trial studies
This study investigates how Sirolimus, a medication known for its immunosuppressive properties, affects the molecular changes associated with cerebral aneurysms. Participants will undergo either microsurgical clipping or endovascular treatment for unruptured cerebral aneurysms while receiving Sirolimus. The goal is to understand the drug's impact on the underlying biology of these aneurysms, potentially leading to improved treatment strategies. The study is being conducted at Jackson Memorial Hospital in Miami, Florida.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for treatment of unruptured cerebral aneurysms at Jackson Memorial Hospital.
Not a fit: Patients with dissecting, traumatic, or mycotic aneurysms, or those with significant comorbidities or contraindications to Sirolimus will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic approaches for managing cerebral aneurysms.
How similar studies have performed: While the use of Sirolimus in this context is novel, similar studies exploring molecular treatments for aneurysms have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Robert M Starke, M.D. — University of Miami
- Study coordinator: Jayro Toledo, MD
- Email: j.toledo2@med.miami.edu
- Phone: 305-243-8044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.