Prospective Measurement of Normal Venous Sinus Pressures

Официальное название

Venous Sinus Pressures in Normal Individuals

Обзор

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.

Подробное описание

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.

1. Insertion of an additional catheter in the femoral vein. 2. 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. 3. 5-10 minutes of additional procedure time. Much of this time period is merely a waiting period while the pressures stabilize and are recorded. 4. 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.

Вмешательства

• Процедура Venogram
  The 5 French (5F) diagnostic catheter will be navigated into the inferior then superior vena cava and then into the internal jugular bulb on the dominant venous side (as determined from the arteriographic images). Next, a 0.027 inch microcatheter will be navigated using fluoroscopic guidance into the superior sagittal sinus and a venogram will then performed by injecting a small dose of contrast. Next, the venous sinus pressure waveforms will be recorded as the catheter is withdrawn into the jug

Первичные конечные точки

• Superior Sagittal Sinus Pressure [Срок оценки: during venogram, up to 10 minutes]
• Torcula Sinus Pressure [Срок оценки: during venogram, up to 10 minutes]
• Dominant Transverse Sinus [Срок оценки: during venogram, up to 10 minutes]
• Dominant Transverse-Sigmoid Sinus Junction [Срок оценки: during venogram, up to 10 minutes]
• Dominant Sigmoid Sinus [Срок оценки: during venogram, up to 10 minutes]
• Dominant Internal Jugular Vein [Срок оценки: during venogram, up to 10 minutes]
• Central Venous Pressures [Срок оценки: during venogram, up to 10 minutes]

Критерии участия

Критерии включения

• Candidates for elective cerebral arteriography

Критерии исключения

• 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 > 35.
• Known diagnosis of heart failure or pulmonary hypertension.
• Pregnant women will be excluded due to the radiation risk associated with Angiogram and Venogram.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Wake Forest Univesity Health Sciences — Winston-Salem

Идентификаторы

NCT: NCT03948971 · IRB00057618

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗