Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021970
Status:
COMPLETED
Last Update Posted:
2016-03-01
First Post:
2001-08-10
Brief Title:
Modifying Oxidative Damage in WAVE - Ancillary to WAVE
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-02
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:
To determine the effects of four treatments placebo a vitamin E and C regimen a hormone replacement regimen and a combined vitaminhormone replacement regimen on specific markers of oxidative damage in coronary arteries of postmenopausal women
Detailed Description:
BACKGROUND
Supplemental vitamin E has been associated with a reduced risk of recurrent myocardial infarctions with efficacy related to dosage and the duration of treatment Its effects may be enhanced by vitamin C an antioxidant that can regenerate vitamin E activity Theoretically vitamin E and C VitEC accumulate in the vascular wall with a concurrent reduction in oxidative damage a primary feature of atherosclerotic lesions Estrogenhormone replacement therapy HRT also may reduce oxidative damage and it may enhance the effect of vitamin E and C These hypotheses are supported by studies defining oxidation-dependent accumulation of lipids in developing atherosclerosis the detection of oxidative damage products such as oxidized-LDL particles in human atherosclerotic lesions and clinical studies associating antioxidant or estrogen supplementation with reductions in oxidative damage cardiovascular disease Nevertheless no human studies have evaluated the effect of long-term VitEC treatment which has been reported as being the most effective prevention factor by epidemiologic studies on specific biochemical markers of oxidative damage and concurrently their association with recurrent cardiovascular disease In addition no studies have characterized the effect of long-term HRT on markers of oxidative damage or HRTs potential synergistic effect with VitEC therapy
DESIGN NARRATIVE
The study assayed specific biochemical measures of oxidative damage all markers at closeout and nitrotyrosine and chlorotyrosine also at baseline in the Womens Angiographic Vitamin and Estrogen WAVE Trial which randomized 420 38-86 year old women with a prior cardiovascular disease event to placebo Vitamin EC hormone replacement therapy HRT or the combination of VitEC and HRT WAVE determined the efficacy of these treatments on quantitative angiographic evaluation of minimal coronary artery diameter performed at baseline and at the final visit to be completed during the first 10 months of 2001 The ancillary study measured oxidation products from several classes of compounds lipids by F2-isoprostanes proteins by nitrotyrosine and chlorotyrosine and DNA by 8-hydroxy-2-deoxyguanosine thereby studying several major pathways that may lead to atherogenesis In addition inflammation with C-reactive protein platelet activation with p-selectin altered lipid metabolism with a lipid profile and other characteristics of the study population were integrated into the assessment of oxidative damage in WAVE By measuring these various factors and by assessing oxidative damage in several classes of compounds the authors tested the relationships among specific pathways of oxidative damage supplemental VitEC andor HRT and other risk factors upon the progression of established macrovascular disease
Supplemental vitamin E has been associated with a reduced risk of recurrent myocardial infarctions with efficacy related to dosage and the duration of treatment Its effects may be enhanced by vitamin C an antioxidant that can regenerate vitamin E activity Theoretically vitamin E and C VitEC accumulate in the vascular wall with a concurrent reduction in oxidative damage a primary feature of atherosclerotic lesions Estrogenhormone replacement therapy HRT also may reduce oxidative damage and it may enhance the effect of vitamin E and C These hypotheses are supported by studies defining oxidation-dependent accumulation of lipids in developing atherosclerosis the detection of oxidative damage products such as oxidized-LDL particles in human atherosclerotic lesions and clinical studies associating antioxidant or estrogen supplementation with reductions in oxidative damage cardiovascular disease Nevertheless no human studies have evaluated the effect of long-term VitEC treatment which has been reported as being the most effective prevention factor by epidemiologic studies on specific biochemical markers of oxidative damage and concurrently their association with recurrent cardiovascular disease In addition no studies have characterized the effect of long-term HRT on markers of oxidative damage or HRTs potential synergistic effect with VitEC therapy
DESIGN NARRATIVE
The study assayed specific biochemical measures of oxidative damage all markers at closeout and nitrotyrosine and chlorotyrosine also at baseline in the Womens Angiographic Vitamin and Estrogen WAVE Trial which randomized 420 38-86 year old women with a prior cardiovascular disease event to placebo Vitamin EC hormone replacement therapy HRT or the combination of VitEC and HRT WAVE determined the efficacy of these treatments on quantitative angiographic evaluation of minimal coronary artery diameter performed at baseline and at the final visit to be completed during the first 10 months of 2001 The ancillary study measured oxidation products from several classes of compounds lipids by F2-isoprostanes proteins by nitrotyrosine and chlorotyrosine and DNA by 8-hydroxy-2-deoxyguanosine thereby studying several major pathways that may lead to atherogenesis In addition inflammation with C-reactive protein platelet activation with p-selectin altered lipid metabolism with a lipid profile and other characteristics of the study population were integrated into the assessment of oxidative damage in WAVE By measuring these various factors and by assessing oxidative damage in several classes of compounds the authors tested the relationships among specific pathways of oxidative damage supplemental VitEC andor HRT and other risk factors upon the progression of established macrovascular disease
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL068397 | NIH | None | httpsreporternihgovquickSearchR01HL068397 |