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

• ClinicalTrials.gov Identifier: NCT01283243
• Recruitment Status: Unknown
• First Posted: January 25, 2011
• Last Update Posted: February 2, 2012
• Sponsor: Yonsei University
• Collaborator: Severance Hospital
• Information provided by (Responsible Party): Yonsei University

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
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified 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

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

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