Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in gene expression from control arteries.
研究概览
简要总结
The objective of this study is to explore the effects of Sirolimus on the underlying molecular alterations of cerebral aneurysms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Microsurgical Clipping Treated with Sirolimus
Participants undergoing standard of care microsurgical clipping of unruptured cerebral aneurysm will be treated with 2 mg Sirolimus daily for 14-18 consecutive days prior to surgery.
干预措施: Microsurgical clipping (Procedure)
Microsurgical Clipping Treated with Sirolimus
Participants undergoing standard of care microsurgical clipping of unruptured cerebral aneurysm will be treated with 2 mg Sirolimus daily for 14-18 consecutive days prior to surgery.
干预措施: Sirolimus (Drug)
Endovascular Treatment Treated with Sirolimus
Participants undergoing standard of care endovascular treatment of unruptured cerebral aneurysm procedure will be treated with 2 mg Sirolimus daily for 14-18 consecutive days prior to procedure.
干预措施: Endovascular treatment (Procedure)
Endovascular Treatment Treated with Sirolimus
Participants undergoing standard of care endovascular treatment of unruptured cerebral aneurysm procedure will be treated with 2 mg Sirolimus daily for 14-18 consecutive days prior to procedure.
干预措施: Sirolimus (Drug)
结局指标
主要结局
Change in gene expression from control arteries.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点
研究者
Robert Starke
Assistant Professor
University of Miami