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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Yonsei University.
Recruitment status was  Recruiting
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

January 21, 2011
February 1, 2012
October 2010
June 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01283243 on ClinicalTrials.gov Archive Site
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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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

HIV patients without abnormal liver function and chronic liver disease

HIV Infection
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
HIV patients with normal liver status
HIV patients without abnormal liver function and chronic liver disease
Intervention: Device: Acoustic radiation force impulse imaging
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2012
June 2012   (final data collection date for primary outcome measure)

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)
Both
20 Years to 80 Years
No
Contact: Seung Up Kim, MD +82-2-2228-2108 ksukorea@yuhs.ac
Contact: Kwang-Hyub Han, MD +82-2-2228-1949 gihankhys@yuhs.ac
Korea, Republic of
 
NCT01283243
1-2010-0027
Yes
Yonsei University
Yonsei University
Severance Hospital
Study Chair: Kwang-Hyub Han, MD Yonsei University Colleage of Medicine
Principal Investigator: Seung Up Kim, MD Yonsei University Colleage of Medicine
Yonsei University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP