Coronary Artery Disease Clinical Trial
Official title:
Hormones and Sexual Function Predict Outcomes in Revascularized Men With Diabetes
The purpose of this study is to find out if androgen deficiency (low levels of testosterone, a male hormone produced by the sex glands) and erectile dysfunction (sexual dysfunction) will predict over time the development of a heart attack, stroke, or death in men with Diabetes Mellitus who have angiographically proven coronary artery disease (CAD) (≥50%) with or without percutaneous coronary intervention (PCI). A substudy aims to show the different factors and processes that may show a relationship between sexual function and levels of androgen in the body to heart disease.
Diabetes mellitus (DM) and multi-vessel coronary artery disease (CAD) entail significant
risk for progression of cardiac morbidity and mortality. Compelling recent research points
to biological pathways that link DM and CAD to androgen status and sexual function. We
hypothesize that androgen deficiency (AD) and erectile dysfunction (ED) independently serve
as sentinel indicators, predicting the future development of adverse cardiovascular and
cerebrovascular events in men with diabetes following coronary revascularization.
ED is emerging as a barometer of overall endothelial function. We hypothesize that as a
consequence of this relationship, erectile dysfunction is predictive of cardiovascular
outcomes in men with diabetes and CAD. We also propose that AD affects morbidity and
mortality in men with DM and CAD by influencing presentation and progression of endothelial
dysfunction as well as inflammation and hemostasis.
We propose to investigate four specific aims using 1,143 diabetic men who have
angiographically proven coronary artery disease (CAD) (≥50%) in at least one major
epicardial vessel with or without percutaneous coronary intervention (PCI). Specific aims of
this study are: 1) To determine whether androgen status at baseline independently predicts
primary and secondary endpoints in men (n=1,143) with DM and CAD. 2) To determine whether
erectile dysfunction at baseline independently predicts cardiovascular outcomes in men with
DM and CAD. 3) To determine whether change of androgen status and sexual function over time
independently predict cardiovascular outcomes in men with DM and CAD. 4) To demonstrate
specific mediators and pathways that link sexual function and androgen status to
cardiovascular disease.
The primary endpoint is defined as the combined all-cause mortality, non-fatal myocardial
infarction (MI), and stroke. Secondary endpoints include major adverse cardiovascular and
cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization
at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6
months, 12 months, 18 months, 24 months, 30 months and 36 months following catheterization.
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Observational Model: Cohort, Time Perspective: Prospective
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