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

This study is currently recruiting participants.
Verified February 2012 by Yonsei University
Sponsor:
Collaborator:
Severance Hospital
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01283243
First received: January 21, 2011
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
HIV Infection
 Device: Acoustic radiation force impulse imaging

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Evaluation of ARFI velocity in HIV patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: ARFI imaging

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HIV patients without abnormal liver function and chronic liver disease

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283243

Contacts
Contact: Seung Up Kim, MD +82-2-2228-2108 ksukorea@yuhs.ac
Contact: Kwang-Hyub Han, MD +82-2-2228-1949 gihankhys@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Seung Up Kim, MD     +82-2-2228-2108     ksukorea@yuhs.ac    
Contact: Kwang-Hyub Han, MD     +82-2-2228-1949     gihankhys@yuhs.ac    
Sub-Investigator: Chang Young Son, MD            
Sponsors and Collaborators
Yonsei University
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
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01283243     History of Changes
Other Study ID Numbers: 1-2010-0027
Study First Received: January 21, 2011
Last Updated: February 1, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
ARFI Imaging
Normal values
HIV infection

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 22, 2013