Assessment of Normal Value of Acoustic Radiation Force Impulse (ARFI) Elastography in HIV Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Yonsei University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Yonsei University
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infection |
Device: Acoustic radiation force impulse imaging |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Yonsei University:
Primary Outcome Measures:
- 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
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
HIV patients with normal liver status
HIV patients without abnormal liver function and chronic liver disease
|
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
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
HIV patients without abnormal liver function and chronic liver disease
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283243
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283243
Contacts
| Contact: Seung Up Kim, MD | +82-2-2228-2108 | ksukorea@yuhs.ac | |
| Contact: Kwang-Hyub Han, MD | +82-2-2228-1949 | gihankhys@yuhs.ac |
Locations
| Korea, Republic of | |
| Severance Hospital | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Seung Up Kim, MD +82-2-2228-2108 ksukorea@yuhs.ac | |
| Contact: Kwang-Hyub Han, MD +82-2-2228-1949 gihankhys@yuhs.ac | |
| Sub-Investigator: Chang Young Son, MD | |
Sponsors and Collaborators
Yonsei University
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 |
More Information
No publications provided
| Responsible Party: | Yonsei University |
| ClinicalTrials.gov Identifier: | NCT01283243 History of Changes |
| Other Study ID Numbers: | 1-2010-0027 |
| Study First Received: | January 21, 2011 |
| Last Updated: | February 1, 2012 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Yonsei University:
|
ARFI Imaging Normal values HIV infection |
Additional relevant MeSH terms:
|
HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections |
Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Virus Diseases |
ClinicalTrials.gov processed this record on February 27, 2015