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Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001589
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: May 2002

November 3, 1999
March 3, 2008
April 1997
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Complete list of historical versions of study NCT00001589 on ClinicalTrials.gov Archive Site
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Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors
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 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.

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.

Observational
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  • Carotid Atherosclerosis
  • Myocardial Infarction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2002
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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.

Both
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Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001589
970113, 97-CC-0113
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National Institutes of Health Clinical Center (CC)
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National Institutes of Health Clinical Center (CC)
May 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP