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
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 21, 2011 | ||||||||
| Last Updated Date | February 1, 2012 | ||||||||
| Start Date ICMJE | October 2010 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01283243 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Assessment of Normal Value of Acoustic Radiation Force Impulse (ARFI) Elastography in HIV Patients | ||||||||
| Official Title ICMJE | 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 ICMJE | Observational | ||||||||
| Study Design ICMJE | 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 ICMJE | HIV Infection | ||||||||
| Intervention ICMJE | 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 Group/Cohort (s) | 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 | ||||||||
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* 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 ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | June 2012 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years to 80 Years (Adult, Senior) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Korea, Republic of | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01283243 | ||||||||
| Other Study ID Numbers ICMJE | 1-2010-0027 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Plan to Share Data | Not Provided | ||||||||
| IPD Description | Not Provided | ||||||||
| Responsible Party | Yonsei University | ||||||||
| Study Sponsor ICMJE | Yonsei University | ||||||||
| Collaborators ICMJE | Severance Hospital | ||||||||
| Investigators ICMJE |
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| Information Provided By | Yonsei University | ||||||||
| Verification Date | February 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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