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
  Purpose

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
Carotid Atherosclerosis
Myocardial Infarction

Study Type: Observational
Official Title: Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 120
Study Start Date: April 1997
Estimated Study Completion Date: May 2002
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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001589

Locations
United States, Maryland
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001589     History of Changes
Other Study ID Numbers: 970113, 97-CC-0113
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

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:
Arteriosclerosis
Atherosclerosis
Carotid Artery Diseases
Infarction
Myocardial Infarction
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014