Trial Outcomes & Findings for The Cardiac Benefit of Testosterone Replacement in Men With Low Testosterone Levels With Coronary Artery Disease After Successful Intervention of the Blockage or Narrowed Heart Artery (NCT NCT00413244)

Subjects recruited for the study were male patients with stable cardiac status at least 3 months after Percutaneous Coronary Intervention (PCI) at the Cardiac Catheterization Lab of Mount Sinai Hospital from July 2007 to August 2013.

The Cardiac Benefit of Testosterone Replacement in Men With Low Testosterone Levels With Coronary Artery Disease After Successful Intervention of the Blockage or Narrowed Heart Artery

Treadmill exercise testing performed according to the Bruce protocol (MAX-1 Marquette advanced exercise system, software version 002E). The system analyzed the signal averaged ECG and produces a graphical display of the level of the ST segment 80 ms after the J point against time. Time to 1 mm ST depression was measured from computer derived analysis, effectively eliminating observer bias.

Exercise capacity was measured using exercise time.

A cardiac disease-related quality-of-life measure. The SAQ is a self-report instrument with 19 items that, yields five subscale scores: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important. Data not collected.

The Reactive Hyperemia Index measures the endothelial function and predicts future coronary events. In general RHI values below 2 are categorized as endothelial dysfunction and have a greater plaque burden, whereas higher RHI values are considered normal or improved endothelial function. PAT is the technique to non-invasively assess endothelial function. It comprises finger probes to evaluate digital volume changes.

IPSS has 7 questions related to symptoms, each item scored 1-5. Total score can range from 0 to 35 (asymptomatic to very symptomatic). The 8th question refers to the patient's perceived quality of life ranged from 0 to 6 ("delighted" to "terrible".) Data not collected.

The Metabolic Equivalent of Task (MET), or simply metabolic equivalent, is a physiological measure expressing the energy cost of physical activities and is defined as the ratio of metabolic rate (and therefore the rate of energy consumption) during a specific physical activity to a reference metabolic rate, set by convention to 3.5 ml O2·kg-1·min-1 or equivalently

The scale assesses symptoms of aging and their impact on HRQoL in males, and increases with increasing severity (1 to 5) of subjectively perceived complaints in 17 items. Scale ranges from 17-85 (no symptoms to extremely severe symptoms.)

Questions 1-5 15 of the IIEF relates to erectile function scale 0 - 30 (severe erectile dysfunction to no erectile dysfunction).

Questions 9-10 of the IIEF relates to orgasmic function scale 0 - 10 (from no impairment to severe impairment)

Questions 11-12 of the IIEF relates to sexual desire scale 0-10 (from very low to very high)

Questions 6,7, 8 of the IIEF relates to intercourse satisfaction scale 0 - 15 (from very dissatisfied to very satisfied)

Questions 13,14 of the IIEF relates to specifically to overall satisfaction scale from 0 - 10 (very dissatisfied to very satisfied)