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

10 augusti 2016 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

568

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Observationsmodeller: Kohort
Tidsperspektiv: Blivande

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Composite outcome of all-cause mortality Tidsram: up to 3 Years	The primary outcome is time to composite outcome of all-cause mortality, MI or stroke.	up to 3 Years

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD. Tidsram: 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. Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Icahn School of Medicine at Mount Sinai

Samarbetspartners

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2010

Primärt slutförande (Faktisk)

1 juli 2016

Avslutad studie (Faktisk)

1 juli 2016

Studieregistreringsdatum

Först inskickad

24 augusti 2010

Först inskickad som uppfyllde QC-kriterierna

27 augusti 2010

Första postat (Uppskatta)

30 augusti 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

11 augusti 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 augusti 2016

Senast verifierad

1 augusti 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

GCO 06-0648
R01DK077954 (U.S.S. NIH-anslag/kontrakt)

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