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Assessment of a B-Mode Ultrasound Technique for the Measurement of Carotid Artery Intima-Media Thickness

Primary Purpose

Atherosclerosis, Myocardial Infarction

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Atherosclerosis focused on measuring Atherosclerosis, Cardiovascular Disease, Computerized Edge Reader, Myocardial Infarction, Risk Factor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Institute of Allergy and Infectious Diseases (NIAID)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001904
Brief Title
Assessment of a B-Mode Ultrasound Technique for the Measurement of Carotid Artery Intima-Media Thickness
Official Title
Assessment of a B-Mode Ultrasound Technique for the Measurement of Carotid Artery Intima-Media Thickness
Study Type
Observational

2. Study Status

Record Verification Date
January 2000
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Myocardial Infarction
Keywords
Atherosclerosis, Cardiovascular Disease, Computerized Edge Reader, Myocardial Infarction, Risk Factor

7. Study Design

Enrollment
50 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
National Institute of Allergy and Infectious Diseases (NIAID)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9027275
Citation
Tan GH, Gharib H. Thyroid incidentalomas: management approaches to nonpalpable nodules discovered incidentally on thyroid imaging. Ann Intern Med. 1997 Feb 1;126(3):226-31. doi: 10.7326/0003-4819-126-3-199702010-00009.
Results Reference
background
PubMed Identifier
7946175
Citation
Mercuri M. Noninvasive imaging protocols to detect and monitor carotid atherosclerosis progression. Am J Hypertens. 1994 Jul;7(7 Pt 2):23S-29S. doi: 10.1093/ajh/7.7.23s.
Results Reference
background

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Assessment of a B-Mode Ultrasound Technique for the Measurement of Carotid Artery Intima-Media Thickness

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