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Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors

Primary Purpose

Carotid Atherosclerosis, Myocardial Infarction

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Carotid Atherosclerosis focused on measuring Ferritin, Atherosclerosis, Myocardial Infarction, Blood Donors, Low Density Lipoprotein, Asymptomatic Carotid Atherosclerosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Warren G. Magnuson Clinical Center (CC)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT00001589
Brief Title
Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors
Official Title
Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors
Study Type
Observational

2. Study Status

Record Verification Date
May 2002
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Atherosclerosis, Myocardial Infarction
Keywords
Ferritin, Atherosclerosis, Myocardial Infarction, Blood Donors, Low Density Lipoprotein, Asymptomatic Carotid Atherosclerosis

7. Study Design

Enrollment
120 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Warren G. Magnuson Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7718033
Citation
Fuster V. Lewis A. Conner Memorial Lecture. Mechanisms leading to myocardial infarction: insights from studies of vascular biology. Circulation. 1994 Oct;90(4):2126-46. doi: 10.1161/01.cir.90.4.2126. Erratum In: Circulation 1995 Jan 1;91(1):256.
Results Reference
background
PubMed Identifier
8185133
Citation
Rader DJ, Hoeg JM, Brewer HB Jr. Quantitation of plasma apolipoproteins in the primary and secondary prevention of coronary artery disease. Ann Intern Med. 1994 Jun 15;120(12):1012-25. doi: 10.7326/0003-4819-120-12-199406150-00008.
Results Reference
background
PubMed Identifier
7586324
Citation
Kannel WB. Clinical misconceptions dispelled by epidemiological research. Circulation. 1995 Dec 1;92(11):3350-60. doi: 10.1161/01.cir.92.11.3350.
Results Reference
background

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Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors

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