Coronary Artery Disease Clinical Trial
— HEART-MENDOfficial 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.
Status | Completed |
Enrollment | 568 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Male age [18-75 years]; - Type 2 Diabetes, defined according to the American Diabetes Association as history of: a) presence of classic symptoms of DM with unequivocal elevation of plasma glucose (2-hour post-prandial or random of >200 mg/dL (11mmol/L), b) fasting plasma glucose elevation on more than 1 occasion of at least 126 mg/dL (7mmol/L) or c) HA1C > 6.5, currently undergoing pharmacological or non-pharmacological treatment; - Angiographically confirmed Coronary Artery Disease (=50%) with or without PCI; - Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia; - Willingness to comply with all follow-up required study visits; and - Signed and received copy of informed consent Exclusion Criteria: - Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment; - Previous stroke within 6 months; - Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during PCI/DES related anticoagulation; - Acute ST-elevation MI (Q-wave) within 72 hours prior to enrollment requiring revascularization; - Abnormal creatine kinase (CK > 2x normal); or abnormal CK-MB levels at time of randomization; - Contraindication to either CABG or PCI/DES because of a coexisting clinical condition]; - Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis; - Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine; - Dementia with a Mini Mental Status Examination (MMSE) score of <20; - Extra-cardiac illness that is expected to limit survival to less than 5 years (e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease); - Geographically inaccessible for follow-up visits required by protocol. - Additional Ancillary Study Exclusions. Exclusion criteria that are unique to the proposed study are prior use of hormonal therapy (HRT) with testosterone in men at baseline and current use of sex-hormone antagonist medications at baseline. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Elmhurst Hospital | Elmhurst | New York |
United States | Hudson Heart Group | Guttenberg | New Jersey |
United States | Winthorp University Hospital | Mineola | New York |
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
United States | Stony Brook University Hospital | Stony Brook | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite outcome of all-cause mortality | The primary outcome is time to composite outcome of all-cause mortality, MI or stroke. | up to 3 Years | No |
Secondary | To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD. | Androgen profile consists of total, free, and bio-available testosterone (T) and testosterone:estradiol ratio. Hypothesis: AD at baseline (defined by total T < 300 ng/dl) will be an independent predictor of primary and secondary outcomes. | Baseline | No |
Secondary | To determine whether erectile dysfunction at baseline independently predicts cardiovascular outcomes in men with DM and CAD. | ED severity will be determined using the International Index of Erectile Function (IIEF), a standard instrument that is available in multiple translations and has excellent cross-cultural validity. Hypothesis: Severe ED at baseline (IIEF < 11), while controlling for demographic and clinical covariates, will be an independent predictor of primary and secondary cardiac outcomes. |
Baseline | No |
Secondary | MACCE | 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, 12, 18, 24, 30 and 36 months following catheterization. | at 6 months following catheterization | No |
Secondary | MACCE | 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, 12, 18, 24, 30 and 36 months following catheterization. | at 12 months following catheterization | No |
Secondary | MACCE | 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, 12, 18, 24, 30 and 36 months following catheterization. | at 18 months following catheterization | No |
Secondary | MACCE | 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, 12, 18, 24, 30 and 36 months following catheterization. | at 24 months following catheterization | No |
Secondary | MACCE | 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, 12, 18, 24, 30 and 36 months following catheterization. | at 30 months following catheterization | No |
Secondary | MACCE | 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, 12, 18, 24, 30 and 36 months following catheterization. | at 36 months following catheterization | No |
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