Recruiting NCT04141020
Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Microsurgical clipping, Endovascular treatment, Sirolimus.
- Who it may be relevant to
- Registry conditions: Cerebral Aneurysm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The objective of this study is to explore the effects of Sirolimus on the underlying molecular alterations of cerebral aneurysms.
Interventions
- Procedure Microsurgical clipping
Standard of care microsurgical clipping of an unruptured cerebral artery aneurysm. - Procedure Endovascular treatment
Standard of care endovascular treatment of an unruptured cerebral artery aneurysm. - Drug Sirolimus
Daily oral Sirolimus 2 mg tablets, adjusted as necessary per treating physician.
Primary outcome measures
- Change in gene expression from control arteries. [Time frame: Day 18]
- Change in gene expression between blood samples. [Time frame: Day 18]
- Change in gene expression. [Time frame: Day 18]
Eligibility criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT04141020 · 20190857 · 1R01NS111119-01A1