Assessment of Normal Value of Acoustic Radiation Force Impulse (ARFI) Elastography in HIV Patients

February 1, 2012 updated by: Yonsei University

Prospective Study for Assessment of Normal Value of Acoustic Radiation Force Impulse (ARFI) Elastography in HIV Patients Without Abnormal Liver Function and Chronic Liver Disease

This is a prospective cohort single center study for assessment of normal value of acoustic radiation force impulse elastography and fibroscan in HIV patients without abnormal liver function and chronic liver disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

HIV positive patients who have liver dysfunction have shown to be correlated with high mortality and morbidity. To date, ARFI elastography has been known to correlate with the degree of liver fibrosis in chronic liver disease. However, ARFI velocity has not yet been reported in HIV patients. The aim of this study was to identify the normal range of ARFI velocity and liver stiffness value by recruiting HIV patients without abnormal liver function and chronic liver disease.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Severance Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Chang Young Son, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HIV patients without abnormal liver function and chronic liver disease

Description

Inclusion Criteria:

  • Age > 20 years
  • HIV positive patients
  • The patients who is willing and able to provide written informed consent to participate in this study

Exclusion Criteria:

  • Co-infected with HIV and HBV or HCV
  • History of any other forms of liver disease
  • Any gross abnormality on the imaging finding including MRI and CT
  • Any laboratory abnormalities regarding liver condition (Platelet count < 150 x 103/ul, Fasting glucose > 110 mg/dl, AST > 40 IU/L, ALT> 40 IU/L, Albumin < 3.3 g/dl, Total bilirubin > 1.2 mg/dl, GGT> 54 IU/L, ALP > 115 IU/L , Ferritin > 322 ng/ml)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIV patients with normal liver status
HIV patients without abnormal liver function and chronic liver disease
Device: Acoustic radiation force impulse imaging
Acoustic radiation force impulse (ARFI) imaging were measured 10 times in each patient.The region of interest was chosen in an area where the normal liver parenchyma was at least 6 cm thick and free of large blood vessels was chosen. A measurement depth of 2 cm below the liver capsule was chosen to standardize the examination.
Other Names:
  • ARFI imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of ARFI velocity in HIV patients
Time Frame: 2 years
Measurement of ARFI velocity is non-invsive ultrasonographic technique. It is performed with a abdominal convex probe which is same probe as conventional ultrasonography. Short-duration acoustic radiation forces result in shear-wave propagation away from the region of excitation and are tracked using ultrasonic correlation-based methods. This results are called ARFI velocity which is expressed as meters per second
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Collaborators

Severance Hospital

Investigators

  • Study Chair: Kwang-Hyub Han, MD, Yonsei University Colleage of Medicine
  • Principal Investigator: Seung Up Kim, MD, Yonsei University Colleage of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

January 21, 2011

First Submitted That Met QC Criteria

January 24, 2011

First Posted (Estimate)

January 25, 2011

Study Record Updates

Last Update Posted (Estimate)

February 2, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2010-0027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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