Assessment of Normal Value of Acoustic Radiation Force Impulse (ARFI) Elastography in HIV Patients
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| 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:
Yonsei University
Collaborator:
Severance Hospital
Information provided by (Responsible Party):
Yonsei University
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment |
|---|---|
| HIV Infection | Device: Acoustic radiation force impulse imaging |
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 |
| Estimated Enrollment : | 100 participants |
| 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 |
| Study Start Date : | October 2010 |
| Estimated Primary Completion Date : | June 2012 |
| Estimated Study Completion Date : | June 2012 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
|
Primary Outcome Measures
:
- 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
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 20 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Yonsei University |
| ClinicalTrials.gov Identifier: | NCT01283243 History of Changes |
| Other Study ID Numbers: |
1-2010-0027 |
| First Posted: | January 25, 2011 Key Record Dates |
| Last Update Posted: | February 2, 2012 |
| Last Verified: | February 2012 |
Keywords provided by Yonsei University:
|
ARFI Imaging Normal values HIV infection |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |