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

Tracking Information
First Submitted Date	January 21, 2011
First Posted Date	January 25, 2011
Last Update Posted Date	February 2, 2012
Study Start Date	October 2010
Estimated Primary Completion Date	June 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: January 24, 2011)	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
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01283243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Assessment of Normal Value of Acoustic Radiation Force Impulse (ARFI) Elastography in HIV Patients
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
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.
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	HIV patients without abnormal liver function and chronic liver disease
Condition	HIV Infection
Intervention	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
Study Groups/Cohorts	HIV patients with normal liver status; HIV patients without abnormal liver function and chronic liver disease; Intervention: Device: Acoustic radiation force impulse imaging
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Unknown status
Estimated Enrollment; (submitted: January 24, 2011)	100
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	June 2012
Estimated Primary Completion Date	June 2012 (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years to 80 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Korea, Republic of
Removed Location Countries
Administrative Information
NCT Number	NCT01283243
Other Study ID Numbers	1-2010-0027
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Yonsei University
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
PRS Account	Yonsei University
Verification Date	February 2012