Venous Sinus Pressures in Normal Individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Dominant Internal Jugular Vein
研究概览
简要总结
The purpose of this research is to document normal intracranial venous sinus pressures. Participants who need to have a cerebral angiogram to evaluate a medical problem not related to Idiopathic Intracranial Hypertension (IIH) will be invited to participate. Participation in this research will not require any extra visits. The intervention will take place in the interventional radiology suite when the subject has an angiogram. IIH is a condition that causes increased pressure in the brain in the absence of a tumor or other diseases that may be causing symptoms. Symptoms include headaches and visual disturbances not explained by other things. In IIH there is a narrowing in the sinuses of the brain that causes the increased pressure.
详细描述
Patients will be prospectively enrolled into the study. All adult patients, aged of 18-60, determined to be candidates for elective cerebral arteriography will be screened for inclusion in this study. Patients consenting to participate and enrolled in the study will first undergo their standard cerebral angiogram procedure, as clinically indicated. Once the procedure is completed, enrolled subjects will then undergo the study intervention.
- Insertion of an additional catheter in the femoral vein.
- Navigation of the catheter into the internal jugular bulb and then catheter navigation into the superior sagittal sinus will result in additional fluoroscopic time (requires ~60 seconds of additional fluoroscopy time; carries a minimum risk of vessel perforation or other untoward event [incidence of complication associated with this procedure in the PI patient series is 0%]). There is additionally some ear pain that can happen with this Venogram.
- 5-10 minutes of additional procedure time. Much of this time period is merely a waiting period while the pressures stabilize and are recorded.
- An additional venogram injection through the catheter which exposes subjects to an additional 1-2 ml of contrast dye and 3-4 seconds of additional fluoroscopy time and its associated radiation dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for elective cerebral arteriography
排除标准
- •All patients with active, or a history of, intracranial venous pathology (arteriovenous malformation, arteriovenous fistulae, idiopathic intracranial hypertension, venous sinus thrombosis).
- •Patients with severe daily headaches or symptoms of idiopathic intracranial hypertension will also be excluded.
- •Body mass index >
- •Known diagnosis of heart failure or pulmonary hypertension.
- •Pregnant women will be excluded due to the radiation risk associated with Angiogram and Venogram.
研究组 & 干预措施
Venogram Group
Participants in this group have a scheduled clinically indicated a cerebral angiogram procedure and will undergo a Venogram.
干预措施: Venogram (Procedure)
结局指标
主要结局
Dominant Internal Jugular Vein
时间窗: during venogram, up to 10 minutes
Dominant internal jugular vein will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Superior Sagittal Sinus Pressure
时间窗: during venogram, up to 10 minutes
Superior sagittal sinus pressure will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Dominant Transverse Sinus
时间窗: during venogram, up to 10 minutes
Dominant transverse sinus will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Dominant Transverse-Sigmoid Sinus Junction
时间窗: during venogram, up to 10 minutes
dominant transverse-sigmoid sinus junction will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Central Venous Pressures
时间窗: during venogram, up to 10 minutes
Central venous pressures will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Dominant Sigmoid Sinus
时间窗: during venogram, up to 10 minutes
Dominant sigmoid sinus will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Torcula Sinus Pressure
时间窗: during venogram, up to 10 minutes
Torcula sinus pressure will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
次要结局
未报告次要终点