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NCT00001589 · ClinicalTrials.gov registry record
Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors
A clinical trial of Myocardial Infarction and Carotid Atherosclerosis, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 120
- Enrollment target
- 1
- Study location
NCT00001589 is a study of Myocardial Infarction and Carotid Atherosclerosis that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 120 participants, below the 4,680-participant average among 64 other Myocardial Infarction trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001589, a study of Myocardial Infarction and Carotid Atherosclerosis, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 120 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Study Locations (1)
Maryland
- Warren G. Magnuson Clinical Center (CC) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 1997-04 |
| Est. Completion | 2002-05 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001589
The ClinicalTrials.gov registry entry for NCT00001589 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,680-participant average among 64 other Myocardial Infarction trials with a reported enrollment target (97% lower). The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Myocardial Infarction appearing as the primary indexed condition, and to 0 interventions.
NCT00001589 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001589 about?
NCT00001589 is a clinical study titled "Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors". 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 caro...
What is the current status of trial NCT00001589?
This trial is currently completed. The enrollment target is 120 participants. The study started on 1997-04. Estimated completion is 2002-05.
What conditions does trial NCT00001589 study?
This clinical trial studies the following conditions: Myocardial Infarction, Carotid Atherosclerosis.
Who is sponsoring clinical trial NCT00001589?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001589 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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