Minimally-Invasive Venogram for Intracranial Venous Hypertension

Overseen By Kimberly Hawley

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Intracranial venous pathology, Severe headaches, BMI > 35, Heart failure, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

10 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Minimally-Invasive Venogram for Intracranial Venous Hypertension?

Research shows that cerebral venography and manometry can effectively identify venous hypertension (high pressure in the veins) in patients with idiopathic intracranial hypertension, which suggests that these techniques can help diagnose and manage conditions involving increased pressure in the brain's veins. ^{1 2 3 4 5}

How is the minimally-invasive venogram treatment different from other treatments for intracranial venous hypertension?

The minimally-invasive venogram treatment is unique because it uses a special technique called venography combined with manometry to measure and address high pressure in the brain's veins, which is not well shown by other imaging methods. This approach is less invasive and potentially more accurate than traditional methods, making it a novel option for diagnosing and managing intracranial venous hypertension. ^{1 2 4 5 6}

Research Team

Kyle Fargen, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for individuals who are scheduled for an elective cerebral angiogram and do not have a history of severe daily headaches, idiopathic intracranial hypertension, or a body mass index over 35. It excludes those with heart failure, pulmonary hypertension, intracranial venous pathology, or pregnancy due to radiation risks.

Inclusion Criteria

I am a candidate for a special brain blood vessel imaging test.

Exclusion Criteria

I do not have severe daily headaches or symptoms of high brain pressure.

I have been diagnosed with heart failure or pulmonary hypertension.

You have a body mass index (BMI) higher than 35, which means you are significantly overweight.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants undergo a standard cerebral angiogram followed by the study intervention involving additional catheter insertion and venogram

10 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any immediate complications following the procedure

1 day

Treatment Details

Interventions

• Venogram

Trial Overview The study aims to measure normal brain vein pressures during a cerebral angiogram in the interventional radiology suite. This will help understand pressure levels in patients without Idiopathic Intracranial Hypertension (IIH), which causes increased brain pressure and symptoms like headaches.

Participant Groups

Group I: Venogram Group Experimental Treatment 1 Intervention

Participants in this group have a scheduled clinically indicated a cerebral angiogram procedure and will undergo a Venogram.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

In a study of nine patients with idiopathic intracranial hypertension, venous hypertension was consistently observed in the superior sagittal sinus and proximal transverse sinuses, indicating a potential mechanism for increased intracranial pressure.

Cerebral venography revealed varying appearances of the transverse sinus, from smooth narrowing to filling defects, but these abnormalities were not clearly visible on standard venous phase angiography, suggesting that manometry may be a more effective diagnostic tool for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral venography and manometry in idiopathic intracranial hypertension. King, JO., Mitchell, PJ., Thomson, KR., et al.[2019]

Cerebral venous sinus thrombosis (CVST) is a rare but important cause of stroke that should be considered when diagnosing intracranial hypertension.

The best diagnostic methods for CVST are CT venogram and MR venography, as standard non-contrast head CT scans may not show abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supine headache and papilledema: A case and review of cerebral venous sinus thrombosis. Pasricha, SV., Bhayana, R., Wu, PE.[2023]

In a study of 63 patients, those diagnosed with idiopathic intracranial hypertension (IIH) showed significantly higher degrees of transverse sinus stenosis compared to controls, indicating that MR venography (MRV) is a valuable tool for diagnosis.

The proposed stenosis classifying index, with a cut-off value of ≥4, demonstrated high sensitivity (94.7%) and specificity (93.5%) for diagnosing IIH, making it a quick and effective method for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new index for the assessment of transverse sinus stenosis for diagnosing idiopathic intracranial hypertension. Carvalho, GB., Matas, SL., Idagawa, MH., et al.[2022]

Dural sinus venography provided clearer details about the site and extent of tumor invasion in all three patients studied, outperforming MR imaging and arteriography.

Pressure measurements during the procedure helped assess the severity of hemodynamic issues caused by narrowed blood vessels, aiding surgical decisions and confirming the patency of critical sinuses that other imaging methods missed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venography and venous pressure monitoring in dural sinus meningiomas. Halbach, VV., Higashida, RT., Hieshima, GB., et al.[2021]

In patients with idiopathic intracranial hypertension, measuring cerebral venous sinus pressure revealed that venous hypertension in the superior sagittal and proximal transverse sinuses is caused by raised intracranial pressure rather than an obstruction in the veins themselves.

The study demonstrated that performing a C1-2 puncture to remove cerebrospinal fluid (CSF) immediately resolves the venous hypertension, confirming that the issue is related to pressure rather than a blockage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manometry combined with cervical puncture in idiopathic intracranial hypertension. King, JO., Mitchell, PJ., Thomson, KR., et al.[2019]

The PrimeWire Prestige pressure guidewire system offers a safe and efficient method for measuring intracranial venous sinus pressure and performing interventions, successfully navigating the complex venous anatomy in patients with idiopathic intracranial hypertension.

This new system simplifies the process compared to traditional microcatheter techniques, providing advantages in terms of speed, accuracy, and potentially lower costs during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venous sinus manometry and intervention using the PrimeWire Prestige pressure guidewire: technique and initial experience. Lopes, DK., Johnson, AK., Tan, LA.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cerebral venography and manometry in idiopathic intracranial hypertension. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Supine headache and papilledema: A case and review of cerebral venous sinus thrombosis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A new index for the assessment of transverse sinus stenosis for diagnosing idiopathic intracranial hypertension. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Venography and venous pressure monitoring in dural sinus meningiomas. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Manometry combined with cervical puncture in idiopathic intracranial hypertension. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Venous sinus manometry and intervention using the PrimeWire Prestige pressure guidewire: technique and initial experience. [2016]