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

10 sierpnia 2016 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Rzeczywisty)

568

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Męski

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: Kohorta
  • Perspektywy czasowe: Spodziewany

Kohorty i interwencje

Grupa / 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Composite outcome of all-cause mortality
Ramy czasowe: up to 3 Years
The primary outcome is time to composite outcome of all-cause mortality, MI or stroke.
up to 3 Years

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD.
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Icahn School of Medicine at Mount Sinai

Współpracownicy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 stycznia 2010

Zakończenie podstawowe (Rzeczywisty)

1 lipca 2016

Ukończenie studiów (Rzeczywisty)

1 lipca 2016

Daty rejestracji na studia

Pierwszy przesłany

24 sierpnia 2010

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 sierpnia 2010

Pierwszy wysłany (Oszacować)

30 sierpnia 2010

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

11 sierpnia 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 sierpnia 2016

Ostatnia weryfikacja

1 sierpnia 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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