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

10 agosto 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

568

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Coorte
  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Composite outcome of all-cause mortality
Lasso di tempo: up to 3 Years
The primary outcome is time to composite outcome of all-cause mortality, MI or stroke.
up to 3 Years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaboratori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2010

Completamento primario (Effettivo)

1 luglio 2016

Completamento dello studio (Effettivo)

1 luglio 2016

Date di iscrizione allo studio

Primo inviato

24 agosto 2010

Primo inviato che soddisfa i criteri di controllo qualità

27 agosto 2010

Primo Inserito (Stima)

30 agosto 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

11 agosto 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 agosto 2016

Ultimo verificato

1 agosto 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GCO 06-0648
  • R01DK077954 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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