Tag: Cardiovascular Health / Endothelial Function*

Coronary Risk Factor Screening and Behavior Change in Women

Title:Coronary Risk Factor Screening and Behavior Change in Women
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:Centers for Disease Control and Prevention
Funding Period:10/98 – 10/99
Study Design:Randomized Prospective Study
Purpose:To compare the effect of conventional cardiac risk factor screening, with and without CT imaging (a form of X-ray) of the coronary arteries, on behavior change related to cardiac risk in post-menopausal women.
Further Study Details:A total of 56 healthy post-menopausal women were given a standard health risk assessment to gauge current medication use and physical activity levels along with blood pressure measures and cholesterol levels. The women were then assigned to one of two groups: conventional cardiac risk factor screening and counseling or conventional screening and counseling plus CT imaging (CT scan) of the coronary arteries. Once the risk assessments were completed, all participants received one tailored counseling session based focusing on nutrition, supplement use, physical activity, weight management, smoking cessation, and appropriate use of hormone replacement therapy and medications for heart disease risk
reduction. In addition to the counseling session, those in the CT group had a CT scan and were shown the X-ray imaging of their coronary arteries. Follow-up assessments were conducted at 6 and 12 months.
Findings:Results from this pilot study suggested that a targeted risk-screening program can promote behavior change in postmenopausal women. However, the addition of a CT scan did not have added benefit to this population.
Eligibility:Postmenopausal women between the ages of 55 and 75 years of age.
Changed at:1/18/2011 5:17 AMChanged by:Judy Treu
Created at:8/31/2010 9:35 AMCreated by:Griffin Hospital

Connecticut WISEWOMAN Project

Title:Connecticut WISEWOMAN Project
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:Connecticut Department of Public Health (DPH)
Funding Period:10/00-9/01
Purpose:The Yale-Griffin Prevention Research Center assisted the Connecticut Department of Public Health in the development of an assessment and counseling tool for the Well-Integrated Screening of Women Across the Nation (WISEWOMAN) program.
Further Study Details:This tool was used to counsel women enrolled in the WISEWOMAN program on reducing risk factors for cardiovascular disease, with a particular focus on promoting physical activity and healthy dietary practices.
Findings:The results support the notion that the revised Dietary Risk Assessment is a reliable and valid dietary assessment tool. The revised Dietary Risk Assessment has the potential to screen for risk factors associated with cardiovascular diseases and to provide effective counseling for heart disease prevention for Connecticut WISEWOMAN participants.
Eligibility:To qualify for this study, you must:
Changed at:1/18/2011 5:24 AMChanged by:Judy Treu
Created at:8/31/2010 9:40 AMCreated by:Griffin Hospital

At-Home Exercise Regimen for Outcome Benefit in Congestive Heart Failure (AEROBIC)

Title:At-Home Exercise Regimen for Outcome Benefit in Congestive Heart Failure (AEROBIC)
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:American Teachers of Preventive Medicine (ATPM)/Centers for Disease Control and Prevention (CDC)
Funding Period:10/00 –4/04
Study Design:Randomized, Controlled, Prospective Study
Purpose:To determine whether the addition of a home-based exercise program to a chronic disease management program provides an effective and safe means of improving the health and functional status of patients with congestive heart failure (CHF).
Further Study Details:Twenty (20) adult men and women enrolled in this study were assigned to one of two groups: a chronic disease management program or chronic disease management plus exercise. Those in the exercise group received a treadmill for use in their home and supervised exercise instruction by a cardiac rehabilitation exercise specialist. This year-long intervention included routine monthly telephone calls, and assessments at 3, 6 and 12 months.
Findings:The home-based exercise intervention caused a significant change in perceived fatigue between study groups after 6 months of study participation, with the control group feeling less fatigued than the intervention group. After 12 months of participation, there were no significant differences in perceived functional capacity. Home-based exercise was well tolerated and favorably evaluated. This pilot study demonstrated the feasibility of studying home-based exercise in patients with moderate congestive heart failure. Larger and longer studies will be required to determine treatment effects.
Eligibility:Adult men and women with an established diagnosis of CHF.
Changed at:1/18/2011 5:20 AMChanged by:Judy Treu
Created at:8/31/2010 9:37 AMCreated by:Griffin Hospital

Assessment of Total Cholesterol/HDL Ratio as a Stable Lab Value for Hospitalized Patients: Changes in Lipid Levels (CLIPS)

Title:Assessment of Total Cholesterol/HDL Ratio as a Stable Lab Value for Hospitalized Patients: Changes in Lipid Levels (CLIPS)
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:The Griffin Hospital Medical Education Library Fund
Funding Period:10/99 – 10/01
Study Design:Prospective trial
Purpose:To assess whether the total cholesterol/HDL ratio remains stable during and after hospitalization as compared to total cholesterol and the remainder of the lipid profile.
Further Study Details:Early treatment of hyperlipidemia (high cholesterol) has been shown to provide benefit; however, total cholesterol is known to vary with acute illness, delaying treatment decisions around the time of hospitalization. A total of 61 patients admitted to Griffin Hospital, an acute care community hospital, with various admitting diagnosis participated in this study to assess changes in lipid profile values. Participants had lipid profiles done at admission, on day 3 of hospitalization (or upon discharge whichever occurred first), and again 4 weeks after discharge.
Findings:In patients hospitalized with various diagnoses, lipid profile values varied significantly during and after the hospital stay, while the ratio of total cholesterol to HDL remained stable. This ratio may serve as a reliable predictor in the early diagnosis and treatment of abnormal cholesterol levels in hospitalized patients.
Eligibility:Male and female patients, between the ages of 30–85 years, admitted to Griffin Hospital and not taking lipid-lowering medication.
Changed at:1/18/2011 5:21 AMChanged by:Judy Treu
Created at:8/31/2010 9:39 AMCreated by:Griffin Hospital

Acute Nutrient Effects on Endothelial Function: A Randomized, Single-Blind Crossover Trial in Healthy Adults

Title:Acute Nutrient Effects on Endothelial Function: A Randomized, Single-Blind Crossover Trial in Healthy Adults
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:The Quaker Oats Company
Funding Period:7/98-6/99
Study Design:Randomized, Single-Blind Crossover Trial
Purpose:To determine the effects of acute and month-long whole grain oat and wheat cereal ingestion on endothelial function in healthy adults following a high-fat meal.
Further Study Details:A total of 50 adults (25 men and 25 women) participated in this study. Participants underwent endothelial function (BARS) testing at the beginning of the study, and after following each of the 3 different treatment assignments – whole grain oatmeal plus high-fat milkshake, wheat cereal plus high-fat milkshake, and vitamin E plus high-fat milkshake. Participants were then assigned, in random order, to 4-week intake of oat and wheat cereals. Endothelial function (BARS) testing was done at the completion of each 4-week treatment assignment.
Findings:The findings confirmed that acute fat ingestion induced endothelial dysfunction in healthy adults. Both vitamin E and oatmeal in the doses tested preserved normal endothelial function when ingested concurrently with a high-fat meal. In the month-long supplementation, oats and wheat had comparable effects on endothelial function. These results suggested that nutrient distribution and meal composition may have had significant implications for cardiovascular health.
Eligibility:Healthy men (35-75 years of age) and women (postmenopausal-75 years of age).
Changed at:1/18/2011 5:15 AMChanged by:Judy Treu
Created at:8/31/2010 9:33 AMCreated by:Griffin Hospital

Randomized, Double-Blind, Placebo-Controlled Trial of Raloxifene on Endothelial Reactivity in Healthy Post-Menopausal Women

Title:Randomized, Double-Blind, Placebo-Controlled Trial of Raloxifene on Endothelial Reactivity in Healthy Post-Menopausal Women
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:Eli Lilly & Co., Inc.
Funding Period:4/99-5/00
Study Design:Randomized, Double-Blind, Placebo-Controlled Crossover Trial
Purpose:Design: Randomized, Double-Blind, Placebo-Controlled Crossover Trial Purpose: To assess the effects of raloxifene (a synthetic estrogen receptor modulator) on blood vessel performance in healthy post-menopausal women. Raloxifene is commonly prescribed for osteoporosis prevention in post-menopausal women; however, cardioprotective effects have not been studied to date.
Further Study Details:The 20 women enrolled in this study were assigned to 2 treatments – raloxifene (60 mg) or placebo daily for 6 weeks. Following each treatment assignment, participants underwent BARS and laser Doppler velocimetry (LDV) testing.
Findings:Treatment with raloxifene was shown to improved blood vessel reactivity as compared to placebo, thus suggesting that raloxifene may have a cardioprotective effect in this population. Additionally, raloxifene was not associated with any more side effects than placebo.
Eligibility:Healthy, post-menopausal woman not taking hormone replacement therapy
Changed at:1/18/2011 5:12 AMChanged by:Judy Treu
Created at:8/31/2010 9:24 AMCreated by:Griffin Hospital

Oats, Antioxidants, and Endothelial Function in Insulin Resistant Adults

Title:Oats, Antioxidants, and Endothelial Function in Insulin Resistant Adults
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:The Quaker Oats Company
Funding Period:10/99-7/01
Study Design:Randomized, Double-Blind, Placebo-Controlled Crossover Trial
Purpose:The purpose of this study was to determine the effects of oats and antioxidant vitamins on endothelial function in adults with features of insulin resistance. While metabolic benefits of soluble fiber-rich grains in insulin resistance (which can lead to diabetes) are well known, effects on endothelial function (a marker of heart health) have not been reported. Eligibility: Adult men (35-75 years of age) and women (postmenopausal-75 years of age) with features of insulin resistance (overweight, hypertriglyceridemia).
Further Study Details:The 30 participants in this study were assigned, in random order, to 4 different treatments: oats plus vitamin E and C, oats plus placebo vitamin E & C, vitamin E & C only, and placebo vitamin E & C. Treatment assignments were taken daily for a period of 6 weeks. Endothelial function (BARS) testing was done at the beginning of the study (after a onetime intake of each treatment), and again following each 6-week assignment.
Findings:Results indicated that oats improved endothelial dysfunction in adults with features of insulin resistance, with particularly strong effects in women. Immediate beneficial effects were found on endothelial function from eating a single bowl of oatmeal, with greater benefit seen from eating oats daily for 6 weeks. These findings were consistent with previous study of oat ingestion in healthy adults (see below). The antioxidant vitamins, E and C, did not provide any benefit, and actually seemed to have a negative effect in the women in this study.
Eligibility:Adult men (35-75 years of age) and women (postmenopausal-75 years of age) with features of insulin resistance (overweight, hypertriglyceridemia).
Changed at:1/18/2011 5:14 AMChanged by:Judy Treu
Created at:8/31/2010 9:31 AMCreated by:Griffin Hospital

Phytoestrogen & Raloxifene EFfects on Endothelial Reactivity (PREFER): Double-blind, Placebo Controlled, Randomized Crossover Trial of Raloxifene versus Soy Phytoestrogens on Endothelial Reactivity in Healthy Post-Menopausal Women

Title:Phytoestrogen & Raloxifene EFfects on Endothelial Reactivity (PREFER): Double-blind, Placebo Controlled, Randomized Crossover Trial of Raloxifene versus Soy Phytoestrogens on Endothelial Reactivity in Healthy Post-Menopausal Women
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:Eli Lilly & Co., Inc.
Funding Period:2/01-3/02
Study Design:Randomized, Double-Blind, Placebo-Controlled Crossover Trial
Purpose:Many women take natural products and/or pharmaceuticals for the treatment of menopause-related conditions. This study was designed to compare the effects of raloxifene (a commonly prescribed medication for the prevention of osteoporosis) and soy phytoestrogens on endothelial function in healthy post-menopausal women. Participants were also surveyed regarding their preference for natural vs. synthetic therapy both before and after the study.
Further Study Details:A total of 25 women who participated in this study were assigned to three different treatments:raloxifene (60 mg),soy phytoestrogen (55 mg), andplaceboin random order each for six weeks. Following each treatment assignment, participants underwent BARS and lipid profile testing.
Findings:Neither of the active treatments (raloxifene or soy phytoestrogens) was found to enhance endothelial function (i.e. provide a protective effect on vascular functioning) in this pilot study. With regard to cholesterol findings, all three treatments (including placebo) were found to significantly lower total cholesterol and LDL from baseline. Further study is required to determine if particular subgroups of postmenopausal women would experience cardiovascular benefit from the use of synthetic or natural forms of estrogen.
Eligibility:Healthy, post-menopausal woman not taking hormone replacement therapy
Changed at:1/18/2011 5:13 AMChanged by:Judy Treu
Created at:8/31/2010 9:22 AMCreated by:Griffin Hospital

Endothelial Function in Response to Sustained Consumption of Soy Protein and Lecithin by Healthy Post-Menopausal Women

Title:Endothelial Function in Response to Sustained Consumption of Soy Protein and Lecithin by Healthy Post-Menopausal Women
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:Eridania Beghin-Say America
Funding Period:7/01-9/03
Study Design:Randomized, Double-Blind, Placebo-Controlled Crossover Trial
Purpose:To determine the effects of certain components of soy (soy isoflavone protein and soy lecithin) on endothelial function in healthy post-menopausal women. If soy, which contains natural phytoestrogens, can be shown to provide the cardiovascular benefit similar to that found in conventional estrogen replacement pharmaceuticals, it may provide an alternative for postmenopausal women who favor “natural” therapies.
Further Study Details:A total of 22 women participated in this study. Participants drank four different combinations of the study beverage (soy isoflavone protein and soy lecithin; soy isoflavone and placebo lecithin; placebo protein and soy lecithin, and placebo protein and placebo lecithin), each twice a day for a 4-week period of time. Brachial Artery Reactivity Scan (BARS) and cholesterol testing was done after completion of each 4-week treatment assignment.
Findings:Endothelial function, assessed as flow-mediated vasodilatation (FMD) of the brachial artery and serum lipid levels, was assessed at baseline and at the end of each 4-week treatment phase. In the sample of healthy postmenopausal women, soy isoflavone protein and soy lecithin significantly improved the lipid profile. However, a favorable influence on endothelial function was not seen, however this could have been due to a small sample size (number of participants).
Eligibility:Healthy post-menopausal women who were not taking HRT, vasoactive medications or cholinesterase inhibitors.
Changed at:1/18/2011 5:11 AMChanged by:Judy Treu
Created at:8/31/2010 9:19 AMCreated by:Griffin Hospital

Randomized, Crossover Study of Endothelial Function Responses to Acute and Sustained Egg Consumption in Healthy Subjects

Title:Randomized, Crossover Study of Endothelial Function Responses to Acute and Sustained Egg Consumption in Healthy Subjects
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:Egg Nutrition Center of the USDA
Funding Period:5/00-6/01
Study Design:Single-Blind Crossover Study
Purpose:To determine the effects of daily egg consumption on endothelial function (or heart health) in healthy adults.
Further Study Details:A total of 49 adults participated in this study. Participants were assigned to two daily treatment breakfasts, in random order, each for a period of 6 weeks:2 eggs, and1 serving of oatmealThe oatmeal breakfast was used as a comparison since oatmeal has been shown to have a beneficial effect on endothelial function. At the end of each 6-week treatment period, participants underwent endothelial function testing (BARS) and cholesterol testing.
Findings:At the end of 6 weeks, cholesterol levels were significantly lower among those who ate oatmeal, while cholesterol levels stayed fairly constant for those who ate eggs. With regard to endothelial function, there was no meaningful difference between the oat and egg treatment, indicating that eating eggs in moderation does not adversely affect endothelial function. These findings are consistent with the view that dietary cholesterol (as found in eggs) may be less detrimental to cardiovascular health than previously thought.
Eligibility:Healthy adults (men over the age of 35 years; women who were post-menopausal and not currently using hormone replacement therapy) with no known coronary artery or other vascular disease and no daily prescription medication use.
Changed at:1/18/2011 5:10 AMChanged by:Judy Treu
Created at:8/31/2010 9:17 AMCreated by:Griffin Hospital