Hormones and Sexual Function Predict Outcomes in Revascularized Men With Diabetes
Condition: Androgen Deficiency; AD; Erectile Dysfunction; ED; Diabetes Mellitus; Coronary Artery Disease; Coronary Revascularization
MeSH terms: Erectile Dysfunction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men with diabetes mellitus (DM) and coronary artery disease (CAD) following
        catheterization.
      
Biospecimen description: 
      Inflammatory markers; Hormones: testosterone, estradiol, SHBG
    
Keywords: Androgen deficiency; Erectile dysfunction; Coronary Artery Disease; Coronary Revascularization; Diabetes mellitus; MI; Stroke; MACCE; DM; ED; CAD; Development of predictive cardiovascular/cerebrovascular AE