CI

At a glance

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N/ACompleted
Drug / intervention
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Likely dose
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Search/NCT00001589
NCT00001589N/ACompleted

Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors

National Institutes of Health Clinical Center (CC)·observational·Posted Nov 4, 1999·Updated Mar 4, 2008

In Brief

An observational study for Carotid Atherosclerosis and Myocardial Infarction. Completed, across 1 site.

Detailed Summary

Iron has been proposed to contribute to atherogenesis in humans by facilitating the oxidation of lipoproteins. This observational study will evaluate the association between frequency of blood donation - expected to be associated with relatively reduced body iron stores in frequent donors - and carotid atherosclerosis. The primary outcome variable will be whether the presence and extent of asymptomatic carotid atherosclerosis as measured by ultrasound is greater in infrequent (less than or equal to 1 donations/year greater than or equal to 5 years) vs. frequent (greater than or equal to 4 donations/year greater than or equal to 5 years) blood donors. Body iron stores, lipid and hemostatic parameters, nitric oxide formation, inflammatory parameters, and markers of vascular oxidative stress will be analyzed as secondary outcome measures. Laboratory analysis and ultrasound testing will be performed blinded to the patient's phlebotomy and iron status. Sixty frequent (n=40 males greater than 40 y/o, n=20 females greater than 50 y/o) and 60 infrequent (n=40 males greater than 40 y/o, n=20 females greater than 50 y/o) blood donors will be recruited for this study from the Department of Transfusion Medicine, W. G. Magnuson Clinical Center. All donors will be assessed for study eligibility and cardiovascular risks during the screening visit. The presence of atherosclerotic lesions by carotid ultrasound and secondary outcome parameters will be assessed during a second visit.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 4, 1999
Enrollment StartApr 1, 1997
Study CompletionMay 1, 2002
TodayJul 2, 2026
Posted 26.7 years ago