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

10 août 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

568

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Modèles d'observation: Cohorte
Perspectives temporelles: Éventuel

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Composite outcome of all-cause mortality Délai: up to 3 Years	The primary outcome is time to composite outcome of all-cause mortality, MI or stroke.	up to 3 Years

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD. Délai: 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. Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Icahn School of Medicine at Mount Sinai

Collaborateurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2010

Achèvement primaire (Réel)

1 juillet 2016

Achèvement de l'étude (Réel)

1 juillet 2016

Dates d'inscription aux études

Première soumission

24 août 2010

Première soumission répondant aux critères de contrôle qualité

27 août 2010

Première publication (Estimation)

30 août 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

11 août 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 août 2016

Dernière vérification

1 août 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

GCO 06-0648
R01DK077954 (Subvention/contrat des NIH des États-Unis)

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