Will Women Interact with Technology to Understand Their Cardiovascular Risk and Potentially Increase Activity?

Cardiovascular disease (CVD) continues to be one of the leading causes of death for women. New approaches need to be identified that will enable women to recognize modifiable risk factors and target their efforts toward prevention. The objectives of this study were to (1) determine if women would access Vivametrica™ to assess CVD risk, (2) identify whether women would increase their physical activity as measured by their daily step counts, and (3) elicit women's opinions about using the system, prospective observational study design. Thirty-six English-speaking women aged 45-64 years of age, without physical disability, were recruited. Participants attended two clinic visits and were asked to wear a sensor-based activity monitor (Garmin Vivosmart® HR Wrist Tracker) for 12 weeks. Twenty-six (72%) of participants accessed Vivametrica for the course of the study. The median number of steps at baseline and at study completion was 9329 (range 5406-18,228) and 10,181 (range 5398-21,401), respectively. There was no significant change in number of steps taken by the participants for the study period (Z = -1.086, p = 0.278). The women's responses to the three statements (related to using Vivametrica) are represented on bar graphs. Women's opinions were important to provide an understanding about how they realized the technology. Women did access Vivametrica. Women did not significantly increase their step count. However, these women were achieving beyond sedentary levels of activity (>5000 steps/day). Although the change in steps was not statistically significant, it represents a median increase in daily steps of 9%, which is clinically important.

Microvascular function predicts cardiovascular events in primary prevention: long-term results from the Firefighters and Their Endothelium (FATE) study.

BACKGROUND: Biomarkers of atherosclerosis may refine clinical decision making in individuals at risk of cardiovascular disease. The purpose of the study was to determine the prognostic significance of endothelial function and other vascular markers in apparently healthy men. METHODS AND RESULTS: The cohort consisted of 1574 men (age, 49.4 years) free of vascular disease. Measurements included flow-mediated dilation and its microvascular stimulus, hyperemic velocity, carotid intima-media thickness, and C-reactive protein. Cox proportional hazard models evaluated the relationship between vascular markers, Framingham risk score, and time to a first composite cardiovascular end point of vascular death, revascularization, myocardial infarction, angina, and stroke. Subjects had low median Framingham risk score (7.9%). Cardiovascular events occurred in 71 subjects (111 events) over a mean follow-up of 7.2±1.7 years. Flow-mediated dilation was not associated with subsequent cardiovascular events (hazard ratio, 0.92; P=0.54). Both hyperemic velocity (hazard ratio, 0.70; 95% confidence interval, 0.54 to 0.90; P=0.006) and carotid intima-media thickness (hazard ratio, 1.45; confidence interval, 1.15 to 1.83; P=0.002) but not C-reactive protein (P=0.35) were related to events in a multivariable analysis that included Framingham risk score (per unit SD). Furthermore, the addition of hyperemic velocity to Framingham risk score resulted in a net clinical reclassification improvement of 28.7% (P<0.001) after 5 years of follow-up in the intermediate-risk group. Overall net reclassification improvement for hyperemic velocity was 6.9% (P=0.24). CONCLUSIONS: In men, hyperemic velocity, the stimulus for flow-mediated dilation, but not flow-mediated dilation itself was a significant risk marker for adverse cardiovascular outcomes. The prognostic value was additive to traditional risk factors and carotid intima-media thickness. Hyperemic velocity, a newly described marker of microvascular function, is a novel tool that may improve risk stratification of lower-risk healthy men.

Effect of angiotensin-converting enzyme inhibition on C-reactive protein levels: the ramipril C-reactive pRotein randomized evaluation (4R) trial results.

BACKGROUND: Plasma levels of the inflammatory biomarker C-reactive protein (CRP) predict cardiovascular risk and may represent a target for treating and/or monitoring risk-reduction strategies. The effect of angiotensin-converting enzyme inhibitors on CRP levels has not been adequately studied. METHODS: A total of 264 men and women, with CRP levels of 2 mg/L or greater and no history of cardiovascular disease, were enrolled in a 12-week randomized, double-blind, placebo-controlled study. Participants were randomly assigned to receive 10 mg/day of ramipril (n=132) or placebo (n=132) for 12 weeks. The main outcome measure was the change in CRP levels from baseline to 12 weeks in the ramipril- versus placebo treated patients. RESULTS: The mean (+/- SD) age was 53+/-9 years (60% men). Baseline demographics were similar between the volunteers allocated to receive either placebo or ramipril. The geometric mean CRP at baseline was 3.84 mg/L (95% CI 3.62 mg/L to 4.06 mg/L). The percentage change in geometric mean CRP values over 12 weeks was --13.2% (95% CI --22.3% to --3.2% ) in the placebo group compared with --21.1% (95% CI --29.9% to --11.2%) in the ramipril group (P nonsignificant), indicating no significant reduction in the primary end point of the trial. CONCLUSIONS: A 12-week ramipril treatment protocol for healthy middle-aged volunteers did not lower CRP levels compared with placebo. However, because of the inherent variability of CRP levels, a much larger study is required to exclude a small treatment effect.

The fate of endothelial function testing: rationale and design of the Firefighters And Their Endothelium (FATE) study.

Endothelial dysfunction plays a pivotal role in the development and progression of atherosclerotic vascular disease. The endothelium is strategically located between blood and vascular smooth muscle, making it both vulnerable to a variety of injurious stimuli but also available for interrogation as a marker of vascular health. Firefighters And Their Endothelium (FATE) is a prospective, longitudinal cohort study designed to assess the relationship between endothelial function, emerging cardiovascular risk factors and ultimately atherosclerotic vascular disease. It is hypothesized that participants with impaired endothelial function will be at increased risk of atherosclerotic complications. This Canadian initiative will recruit 1600 middle-aged participants with no known history of cardiovascular disease to be followed for cardiovascular events over the next decade. Quantitative B-mode ultrasound will be employed to assess endothelial function and subclinical atherosclerosis. This research is designed to redefine the approach to the primary prevention of atherosclerosis.

Chelation therapy for ischemic heart disease: a randomized controlled trial.

CONTEXT: Chelation therapy using EDTA is an unproven but widely used alternative therapy for ischemic heart disease. OBJECTIVE: To determine if current EDTA protocols have a favorable impact on exercise ischemia threshold and quality of life measures in patients with stable ischemic heart disease. DESIGN: Double-blind, randomized, placebo-controlled trial conducted between January 1996 and January 2000. SETTING: Participants were recruited from a cohort of cardiac catheterization patients and the practices of cardiologists in Calgary, Alberta. PARTICIPANTS: We screened 3140 patients, performed a qualifying treadmill test in 171, and enrolled 84. Entry criteria included age at least 21 years with coronary artery disease proven by angiography or a documented myocardial infarction and stable angina while receiving optimal medical therapy. The required treadmill test used a gradual ramping protocol and patients had to demonstrate at least 1-mm ST depression. INTERVENTIONS: Patients were randomly assigned to receive infusion with either weight-adjusted (40 mg/kg) EDTA chelation therapy (n = 41) or placebo (n = 43) for 3 hours per treatment, twice weekly for 15 weeks and once per month for an additional 3 months. Patients in both groups took oral multivitamin therapy as well. MAIN OUTCOME MEASURE: Change from baseline to 27-week follow-up in time to ischemia (1-mm ST depression). RESULTS: Thirty-nine patients in each group completed the 27-week protocol. One chelation patient had therapy discontinued for a transient rise in serum creatinine. The mean (SD) baseline exercise time to ischemia was 572 (172) and 589 (176) seconds in the placebo and chelation groups, respectively. The corresponding mean changes in time to ischemia at 27 weeks were 54 seconds (95% confidence interval [CI], 23-84 seconds; P<.001) and 63 seconds (95% CI, 29-95 seconds; P<.001), for a difference of 9 seconds (95% CI, -36 to 53 seconds; P =.69). Exercise capacity and quality of life scores improved by similar degrees in both groups. CONCLUSION: Based on exercise time to ischemia, exercise capacity, and quality of life measurements, there is no evidence to support a beneficial effect of chelation therapy in patients with ischemic heart disease, stable angina, and a positive treadmill test for ischemia.