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
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Sponsor:
Yonsei University
Collaborator:
Severance Hospital
Information provided by (Responsible Party):
Yonsei University
Tracking Information | |||||||
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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 |
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
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
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 |
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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
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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
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Unknown status | ||||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Yonsei University | ||||||
Verification Date | February 2012 |