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

NCT01283243 | Unknown DMC

• 1 other identifier: 1-2010-0027
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection

Keywords

ARFI Imaging; Normal values; HIV infection

Outcome Measures

Primary Outcomes (1)

• Evaluation of ARFI velocity in HIV patients

  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

  2 years

Study Arms (1)

HIV patients with normal liver status

HIV patients without abnormal liver function and chronic liver disease

Device: Acoustic radiation force impulse imaging

Interventions

Acoustic radiation force impulse imaging 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.

Also known as: ARFI imaging

HIV patients with normal liver status

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV patients without abnormal liver function and chronic liver disease

You may qualify if:

• Age \> 20 years
• HIV positive patients
• The patients who is willing and able to provide written informed consent to participate in this study

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead
• Severance Hospital: collaborator

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Kwang-Hyub Han, MD

  Yonsei University Colleage of Medicine

  STUDY CHAIR

• Seung Up Kim, MD

  Yonsei University Colleage of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung Up Kim, MD

CONTACT

+82-2-2228-2108; ksukorea@yuhs.ac

Kwang-Hyub Han, MD

CONTACT

+82-2-2228-1949; gihankhys@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 25, 2011
• Study Start: October 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 2, 2012

Record last verified: 2012-02

Locations

KR (1)