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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01283243
Enrollment
100
Registered
2011-01-25
Start date
2010-10-31
Completion date
2012-06-30
Last updated
2012-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

ARFI Imaging, Normal values, HIV infection

Brief summary

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.

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.

Interventions

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.

Sponsors

Severance Hospital
CollaboratorOTHER
Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of ARFI velocity in HIV patients2 yearsMeasurement 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

Countries

South Korea

Contacts

Primary ContactSeung Up Kim, MD
ksukorea@yuhs.ac+82-2-2228-2108
Backup ContactKwang-Hyub Han, MD
gihankhys@yuhs.ac+82-2-2228-1949

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026