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Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors

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ClinicalTrials.gov Identifier: NCT00001589
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Description
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Brief 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.

Condition or disease
Carotid Atherosclerosis Myocardial Infarction

Detailed Description:
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 Design
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Study Type : Observational
Enrollment : 120 participants
Official Title: Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors
Study Start Date : April 1997
Study Completion Date : May 2002

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA:

Age greater than or equal to 40 years for males and greater than or equal to 50 years for females.

Standard eligibility criteria for blood donation, per guidelines established by the Food and Drug Administration and the American Association of Blood Banks.

Ability to provide consent after full information is provided.

EXCLUSION CRITERIA:

Pregnancy or lactation.

Patients with clinically significant dementia or psychiatric disturbances, including alcohol and substance abuse.

Presence of the following American Heart Association cardiovascular risks: diabetes mellitus, hypertension (systolic greater than 140 mmHg, diastolic greater than 90 mmHg), smoking (greater than 10 cigarettes/day), high density lipoprotein cholesterol less than 35 mg/dL, hyperlipidemia (total cholesterol greater than 240 mg/dL), family history of premature coronary heart disease.

Anticoagulant, thrombolytic, hemorrheologic and/or antiplatelet agents (within the last 10 days).

Any other condition or therapy which in the opinion of the investigators may pose a risk to the patient or confound the results of the study.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001589


Locations
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United States, Maryland
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00001589    
Other Study ID Numbers: 970113
97-CC-0113
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: May 2002
Keywords provided by National Institutes of Health Clinical Center (CC):
Ferritin
Atherosclerosis
Myocardial Infarction
 Blood Donors
Low Density Lipoprotein
Asymptomatic Carotid Atherosclerosis
Additional relevant MeSH terms:
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Carotid Artery Diseases
Myocardial Infarction
Atherosclerosis
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases