Assessment of Portal Hypertension With Multiparametric MRI



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:8/29/2018
Start Date:December 12, 2017
End Date:November 30, 2021
Contact:Yair Bitton, MPH, MBA
Email:yair.bitton@mountsinai.org
Phone:212-824-8475

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The purpose of this study is to determine whether new multiparametric magnetic resonance
imaging (MRI) methods (including diffusion-weighted MRI, dynamic contrast-enhanced MRI, MR
elastography and phase-contrast imaging) can be useful in assessing liver damage and degree
of portal hypertension (a complication of advanced liver fibrosis and cirrhosis) secondary to
chronic liver disease, compared to ultrasound measurement of liver stiffness [acoustic
radiation force impulse (ARFI) ultrasound] and routine blood tests. MRI uses magnetic fields
to look at soft tissues in the body. This study will ultimately help to determine whether
these methods will be useful in identifying liver disease and their complications that cannot
be well-understood using current liver MRI techniques.

Liver cirrhosis has been historically classified as a single histopathologic entity, as it is
considered to be the latest fibrosis stage; however it is well known that cirrhosis
encompasses different degrees of clinical severity. Advanced liver fibrosis and cirrhosis are
commonly associated with portal hypertension, which is due to increased hemodynamic
resistance of the liver leading to an increase in portal venous pressure. Portal hypertension
leads to the development of esophageal varices associated with a high risk of bleeding,
ascites and renal dysfunction. The definite diagnosis of portal hypertension is based on the
measurement hepatic venous pressure gradient (HVPG), which is an indirect measure of portal
pressure. This technique is invasive and not widely available. Portal hypertension may also
be associated with a decrease in portal venous flow/velocity due to a higher parenchymal
resistance to flow, and an increase in hepatic arterial flow secondary to an arterial buffer
response that can be measured with phase-contrast magnetic resonance imaging (MRI). According
to the researcher's recent data, the increased vascular pressure observed in portal
hypertension affects liver and spleen stiffness as well as other viscoelastic properties
measured with advanced 3D MR elastography, which may potentially be used as biomarkers of
portal hypertension.

In this proposal, the researchers would like to validate noninvasive imaging biomarkers based
on a short multiparametric MRI protocol for the quantification of changes in viscoelastic
properties and flow metrics in the liver and spleen in relation to portal hypertension. This
protocol could potentially be integrated in routine clinical MRI exams, and could
significantly reduce the cost of care by decreasing the need for HVPG measurement, upper
gastrointestinal endoscopies, and could provide a novel risk stratification scoring system of
liver disease and portal hypertension based on MRI. This will be a highly significant
progression in patients with liver disease.

Inclusion Criteria:

- Chronic liver disease (including all etiologies of liver disease)

- 18 years of age and older

- Patient is able to give informed consent for this study

- Patients preferably (but not necessarily) underwent/will undergo:

1. Liver biopsy (percutaneous or transjugular or surgical) performed within 6
months, as part of routine clinical care and/or HVPG measurement as part of their
clinical care (within 6 months) and/or clinically indicated upper
gastrointestinal endoscopy.

and/or

2. Liver transplant or liver resection performed as part of routine clinical care
and/or

3. Medical therapy for portal hypertension or TIPS placement as part of routine
clinical care.

Control group

- Healthy volunteers without history of liver disease (will be used for the purpose of
image optimization). These subjects will NOT undergo HVPG measurement.

- 18 years of age and older

Exclusion Criteria:

- Age less than 18 years

- Unable or unwilling to give informed consent

- Contra-indications to MRI

1. Electrical implants such as cardiac pacemakers or perfusion pumps

2. Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses
artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos
near the eye, or steel implants

3. Ferromagnetic objects such as jewelry or metal clips in clothing

4. Pregnant subjects

5. Pre-existing medical conditions including a likelihood of developing seizures or
claustrophobic reactions.
We found this trial at
1
site
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Phone: 212-824-8475
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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