NCT00001589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

May 1, 2002

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Carotid AtherosclerosisMyocardial Infarction

Keywords

FerritinAtherosclerosisMyocardial InfarctionBlood DonorsLow Density LipoproteinAsymptomatic Carotid Atherosclerosis

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 7718033BACKGROUND

  • 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.

    PMID: 8185133BACKGROUND

  • Kannel WB. Clinical misconceptions dispelled by epidemiological research. Circulation. 1995 Dec 1;92(11):3350-60. doi: 10.1161/01.cir.92.11.3350.

    PMID: 7586324BACKGROUND

MeSH Terms

Conditions

Carotid Artery DiseasesMyocardial InfarctionAtherosclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisArteriosclerosisArterial Occlusive Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

April 1, 1997

Study Completion

May 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-05

Locations

US(1)