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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | April 1999 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001904 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Assessment of a B-Mode Ultrasound Technique for the Measurement of Carotid Artery Intima-Media Thickness |
| Official Title ICMJE | Assessment of a B-Mode Ultrasound Technique for the Measurement of Carotid Artery Intima-Media Thickness |
| Brief Summary | This minimal risk protocol is designed to assess the reproducibility of B-mode ultrasound measurements of carotid intima media thickness (IMT) when the scans are performed in CC Radiology and read using a computerized edge reader. Up to 20 volunteers will have two ultrasounds performed within a 6-month period. IMT thickness is used as a surrogate marker for atherosclerosis and may be of value in clinical trials. |
| Detailed Description | This minimal risk protocol is designed to assess the reproducibility of B-mode ultrasound measurements of carotid intima-media thickness (IMT) when the scans are performed in CC Radiology and read using a computerized edge reader. Up to 50 volunteers will have two ultrasounds performed within a 6-month period. IMT thickness is used as a surrogate marker for atherosclerosis and may be of value in clinical trials. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 50 |
| Completion Date | September 2000 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Adult (age 18 or older). Desire to participate in the study; willing and able to provide informed consent. No history of stroke or carotid disease. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001904 |
| Responsible Party | |
| Study ID Numbers ICMJE | 990085, 99-I-0085 |
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | January 2000 |
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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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