Ignite Creation Date:
2024-05-05 @ 10:48 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01190904
Status:
COMPLETED
Last Update Posted:
2016-08-11
First Post:
2010-08-24
Brief Title:
Hormones and Sexual Function Predict Outcomes in Revascularized Men With Diabetes
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Hormones and Sexual Function Predict Outcomes in Revascularized Men With Diabetes
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEART-MEND
Brief 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 1143 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 n1143 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
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 1143 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 n1143 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK077954 | NIH | None | httpsreporternihgovquickSearchR01DK077954 |