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Modifying Oxidative Damage in WAVE - Ancillary to WAVE

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00021970
First Posted: August 10, 2001
Last Update Posted: March 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
  Purpose
To determine the effects of four treatments (placebo, a vitamin E and C regimen, a hormone replacement regimen, and a combined vitamin/hormone replacement regimen) on specific markers of oxidative damage in coronary arteries of postmenopausal women.

Condition
Cardiovascular Diseases Coronary Disease Heart Diseases

Study Type: Observational
Study Design: Time Perspective: Retrospective

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Study Start Date: April 2001
Estimated Study Completion Date: March 2005
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 (VitE/C) accumulate in the vascular wall with a concurrent reduction in oxidative damage, a primary feature of atherosclerotic lesions. Estrogen/hormone 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 VitE/C 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 HRT's potential synergistic effect with VitE/C 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 Women's Angiographic Vitamin and Estrogen (WAVE) Trial, which randomized 420 38-86 year old women with a prior cardiovascular disease event to placebo, Vitamin E/C, hormone replacement therapy (HRT) or the combination of VitE/C 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 VitE/C and/or HRT and other risk factors upon the progression of established macrovascular disease.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   38 Years to 86 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021970


Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Michael Steffes University of Minnesota - Clinical and Translational Science Institute
  More Information

ClinicalTrials.gov Identifier: NCT00021970     History of Changes
Other Study ID Numbers: 979
R01HL068397 ( U.S. NIH Grant/Contract )
First Submitted: August 10, 2001
First Posted: August 10, 2001
Last Update Posted: March 1, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases