Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001589
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors
Status:
COMPLETED
Status Verified Date:
2002-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 donationsyear greater than or equal to 5 years vs frequent greater than or equal to 4 donationsyear 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 patients phlebotomy and iron status Sixty frequent n40 males greater than 40 yo n20 females greater than 50 yo and 60 infrequent n40 males greater than 40 yo n20 females greater than 50 yo 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 donationsyear greater than or equal to 5 years vs frequent greater than or equal to 4 donationsyear 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 patients phlebotomy and iron status Sixty frequent n40 males greater than 40 yo n20 females greater than 50 yo and 60 infrequent n40 males greater than 40 yo n20 females greater than 50 yo 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-CC-0113 | None | None | None |