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

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ClinicalTrials.gov Identifier: NCT01283243
Recruitment Status : Unknown
Verified February 2012 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : January 25, 2011
Last Update Posted : February 2, 2012
Sponsor:
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
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 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

*   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