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

Tracking Information

First Received Date ^ICMJE

January 21, 2011

Last Updated Date

February 1, 2012

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01283243 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

HIV Infection

Intervention ^ICMJE

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 Group/Cohort (s)

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 ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

June 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01283243

Other Study ID Numbers ^ICMJE

1-2010-0027

Has Data Monitoring Committee

Yes

Responsible Party

Yonsei University

Study Sponsor ^ICMJE

Yonsei University

Collaborators ^ICMJE

Severance Hospital

Investigators ^ICMJE

Study Chair:	Kwang-Hyub Han, MD	Yonsei University Colleage of Medicine
Principal Investigator:	Seung Up Kim, MD	Yonsei University Colleage of Medicine

Information Provided By

Yonsei University

Verification Date

February 2012

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

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