Modifying Oxidative Damage in WAVE - Ancillary to WAVE

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00021970
First received: August 10, 2001
Last updated: July 11, 2005
Last verified: July 2005
  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: Longitudinal

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

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

Ages Eligible for Study:   38 Years to 86 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00021970

Sponsors and Collaborators
Investigators
Investigator: Michael Steffes University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00021970     History of Changes
Other Study ID Numbers: 979
Study First Received: August 10, 2001
Last Updated: July 11, 2005
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 16, 2014