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

NCT ID: NCT01283243

Last Updated: 2012-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-06-30

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.

Conditions

HIV Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV patients with normal liver status

HIV patients without abnormal liver function and chronic liver disease

Acoustic radiation force impulse imaging

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ARFI imaging

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Severance Hospital

OTHER

Sponsor Role: collaborator

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kwang-Hyub Han, MD

Role: STUDY_CHAIR

Yonsei University Colleage of Medicine

Seung Up Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University Colleage of Medicine

Locations

Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Seung Up Kim, MD

Role: CONTACT

ksukorea@yuhs.ac

+82-2-2228-2108

Kwang-Hyub Han, MD

Role: CONTACT

gihankhys@yuhs.ac

+82-2-2228-1949

Facility Contacts

Seung Up Kim, MD

Role: primary

ksukorea@yuhs.ac

+82-2-2228-2108

Kwang-Hyub Han, MD

Role: backup

gihankhys@yuhs.ac

+82-2-2228-1949

Other Identifiers

1-2010-0027

Identifier Type: -

Identifier Source: org_study_id