Prospective Measurement of Normal Venous Sinus Pressures
ConditionIntracranial Venous Pressures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Candidates for elective cerebral arteriography
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Venogram
Procedure/SurgeryThe 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 Next, the venous sinus pressure waveforms will be recorded as the catheter is withdrawn into the jugular bulb and then in the superior vena cava to obtain a central venous pressure. Once completed, the catheters will be removed and the sheaths will be removed. Manual pressure will be held at the venous access site for a few minutes. The arterial sheath will be closed based upon standard arteriogram protocol.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Venogram GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
Superior Sagittal Sinus Pressure
Superior sagittal sinus pressure will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Time frame
during venogram, up to 10 minutes2
Torcula Sinus Pressure
Torcula sinus pressure will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Time frame
during venogram, up to 10 minutes3
Dominant Transverse Sinus
Dominant transverse sinus will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Time frame
during venogram, up to 10 minutes4
Dominant Transverse-Sigmoid Sinus Junction
dominant transverse-sigmoid sinus junction will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Time frame
during venogram, up to 10 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov