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NCT04867954 · ClinicalTrials.gov registry record
Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
A clinical trial of Cirrhosis, Liver and Gastroesophageal Varices, sponsored by University of Wisconsin, Madison.
- Recruiting
- Registry status
- 146
- Enrollment target
- 1
- Study location
NCT04867954 is a study of Cirrhosis, Liver and Gastroesophageal Varices that is actively recruiting participants, run by University of Wisconsin, Madison. The registered enrollment target is 146 participants, below the 238-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04867954, a study of Cirrhosis, Liver and Gastroesophageal Varices, is actively recruiting participants, sponsored by University of Wisconsin, Madison.
- RECRUITING
- Registry status
- 146 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this research is to validate novel non-invasive Magnetic resonance imaging (MRI) biomarkers to detect Gastroesophageal varices (GEV) in patients with cirrhosis, including fractional flow change in the portal vein and elevated azygos flow. End-stage liver disease (cirrhosis) is characterized by advanced fibrosis, liver failure, and portal hypertension. There are many causes of cirrhosis, including viral hepatitis, alcohol abuse, and perhaps most importantly, non-alcoholic fatty liver disease (NAFLD) and its aggressive subset, non-alcoholic steatohepatitis (NASH). 3 million new cases of end-stage liver disease (cirrhosis) are expected over the next decade. In cirrhosis, portosystemic collaterals that shunt blood away from the liver develop due to increased portal pressure. Gastroesophageal varices (GEV) are the most clinically relevant because they can cause fatal internal bleeding. GEV bleeding carries \~20% mortality at 6 weeks, and \~34% overall mortality. Identification of at-risk varices, prior to bleeding, is of paramount importance to initiate primary prophylaxis. To identify and treat at-risk patients, current guidelines recommend regular esophagogastroduodenoscopy (EGD) and variceal band ligation. Detection of high-risk GEV is key to initiating primary prophylaxis, which can reduce mortality by 50-70%. However, endoscopy is invasive and often unnecessary when no treatment is required. Therefore, the American Association for the Study of Liver Diseases has identified the development of "non-invasive markers that predict the presence of high-risk varices" as a major unmet need.
Conditions Studied
Interventions
- OTHER Ensure Plus®
- OTHER Pre-clinical validation contrast enhanced MRI
- OTHER Clinical validation MRI
- OTHER Pre-clinical validation contrast enhanced MRI + fasting
Study Locations (1)
Wisconsin
- University of Wisconsin, Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2021-10-28 |
| Est. Completion | 2026-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04867954
The ClinicalTrials.gov registry entry for NCT04867954 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 238-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (39% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Cirrhosis, Liver appearing as the primary indexed condition, and to 4 interventions - of which Ensure Plus® is the first listed.
NCT04867954 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04867954 about?
NCT04867954 is a clinical study titled "Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis". The goal of this research is to validate novel non-invasive Magnetic resonance imaging (MRI) biomarkers to detect Gastroesophageal varices (GEV) in patients with cirrhosis, including fractional flow change in the portal vein and elevated azygos flow. End-stage liver disease (cirrhosis) is character...
What is the current status of trial NCT04867954?
This trial is currently recruiting. The enrollment target is 146 participants. The study started on 2021-10-28. Estimated completion is 2026-04.
What conditions does trial NCT04867954 study?
This clinical trial studies the following conditions: Cirrhosis, Liver, Gastroesophageal Varices, Fontan Procedure.
What interventions are being tested in trial NCT04867954?
The interventions under investigation include: Ensure Plus® (OTHER), Pre-clinical validation contrast enhanced MRI (OTHER), Clinical validation MRI (OTHER), Pre-clinical validation contrast enhanced MRI + fasting (OTHER).
Who is sponsoring clinical trial NCT04867954?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04867954 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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