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Hormones and Sexual Function Predict Outcomes in Revascularized Men With Diabetes (HEART-MEND)

10. srpna 2016 aktualizováno: Icahn School of Medicine at Mount Sinai
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.

Přehled studie

Postavení

Dokončeno

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

568

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • New Jersey
      • Guttenberg, New Jersey, Spojené státy, 07093
        • Hudson Heart Group
    • New York
      • Elmhurst, New York, Spojené státy, 11373
        • Elmhurst Hospital
      • Mineola, New York, Spojené státy, 11501
        • Winthorp University Hospital
      • New York, New York, Spojené státy, 10029
        • Icahn School of Medicine at Mount Sinai
      • Stony Brook, New York, Spojené státy, 11794
        • Stony Brook University Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 75 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Mužský

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Men with diabetes mellitus (DM) and coronary artery disease (CAD) following catheterization.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Observační modely: Kohorta
  • Časové perspektivy: Budoucí

Kohorty a intervence

Skupina / kohorta
Coronary Artery Disease (≥50%) with or without PCI
We propose to investigate four specific aims using 1,143 diabetic men who have CAD (≥50%) lesion in at least one major epicardial vessel with or without PCI.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Composite outcome of all-cause mortality
Časové okno: up to 3 Years
The primary outcome is time to composite outcome of all-cause mortality, MI or stroke.
up to 3 Years

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD.
Časové okno: Baseline
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
To determine whether erectile dysfunction at baseline independently predicts cardiovascular outcomes in men with DM and CAD.
Časové okno: Baseline

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
MACCE
Časové okno: at 6 months following catheterization
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
MACCE
Časové okno: at 12 months following catheterization
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
MACCE
Časové okno: at 18 months following catheterization
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
MACCE
Časové okno: at 24 months following catheterization
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
MACCE
Časové okno: at 30 months following catheterization
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
MACCE
Časové okno: at 36 months following catheterization
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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Icahn School of Medicine at Mount Sinai

Spolupracovníci

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. ledna 2010

Primární dokončení (Aktuální)

1. července 2016

Dokončení studie (Aktuální)

1. července 2016

Termíny zápisu do studia

První předloženo

24. srpna 2010

První předloženo, které splnilo kritéria kontroly kvality

27. srpna 2010

První zveřejněno (Odhad)

30. srpna 2010

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

11. srpna 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. srpna 2016

Naposledy ověřeno

1. srpna 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • GCO 06-0648
  • R01DK077954 (Grant/smlouva NIH USA)

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