Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study (MMAPPS)
15 marzo 2017 aggiornato da: Steven K. Grinspoon, MD, Massachusetts General Hospital
The main aims of this study are to determine whether: a) psoriasis patients with or without arthritis have more cardiovascular inflammation than healthy subjects and b)3 months of etanercept (enbrel) therapy (prescribed to psoriasis patients with or without arthritis by their treating clinicians) will decrease cardiovascular inflammation.
Panoramica dello studio
Stato
Terminato
Condizioni
Descrizione dettagliata
Psoriasis is a common disease characterized by skin lesions and systemic inflammation with or without arthritis.
Patients with psoriasis have a higher risk of cardiovascular disease than healthy subjects, and this may be related in part to the inflammatory nature of their disease.
This study is intended to help provide explanations for the increased cardiovascular disease risk in psoriasis and to assess whether this risk can be reduced by biologic anti-inflammatory therapies prescribed to resolve skin lesions and arthritis.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
29
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
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Massachusetts General Hospital
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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 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Subjects with moderate-to-severe psoriasis with or without arthritis will be recruited primarily from dermatology and rheumatology clinics in the eastern Massachusetts area.
Descrizione
FOR PSORIASIS PATIENTS
Inclusion Criteria:
-men and women age 18-80 with moderate-to-severe psoriasis (with or without arthritis) newly initiating biologic therapy with etanercept (enbrel) 50 mg once or twice weekly
Exclusion Criteria:
- pregnancy or breastfeeding
- women of child-bearing potential refusing to practice abstinence or to use a reliable barrier form of birth control including condoms, IUD, or diaphragm
- history of acute coronary syndrome or coronary artery stenting or surgery, or significant autoimmune/inflammatory disease other than psoriasis or a related psoriatic condition
- previous therapy for psoriasis with a biologic agent within the past 4 months
- new initiation of a statin or antihyperglycemic agent within the past 3 months
- screening hemoglobin < 11
- conditions which would make MDCT coronary angiography/ cardiac FDG-PET protocol unsafe or unfeasible including: significant renal dysfunction with an eGFR by Cockcroft-Gault equation of <60 ml/min, contrast dye allergy, contraindication to beta-blockers (e.g. severe asthma, hypotension, or heart block), or contraindication to nitroglycerin (uninterruptable administration of phosphodiesterase inhibitors), body weight greater than 320 lbs (PET scanner table limitation)
report by subject of any significant radiation exposure over the course of the year prior to enrollment; significant exposure is defined as:
- more than 2 myocardial perfusion studies within the past 12 months
- more than 2 CT angiograms within the past 12 months
- concurrent enrollment in a clinical trial judged by the investigator to introduce concerns about safety or confounding
FOR HEALTHY CONTROL SUBJECTS
Inclusion Criteria:
-men and women age 18-80 without psoriasis
Exclusion Criteria:
- pregnancy or breastfeeding
- women of child-bearing potential refusing to practice abstinence or to use a reliable barrier form of birth control including condoms, IUD, or diaphragm
- history of acute coronary syndrome or coronary artery stenting or surgery, or significant autoimmune/inflammatory disease
- screening hemoglobin < 11
- conditions which would make MDCT coronary angiography/ cardiac FDG-PET protocol unsafe or unfeasible including: significant renal dysfunction with an estimated creatinine clearance by Cockcroft-Gault equation of <60 ml/min, contrast dye allergy, contraindication to beta-blockers (e.g. severe asthma, hypotension, or heart block), or contraindication to nitroglycerin (e.g. continuous administration of phosphodiesterase inhibitors), body weight greater than 320 lbs PET scanner table limitation)
report by subject of any significant radiation exposure over the course of the year prior to enrollment; significant exposure is defined as:
- more than 2 myocardial perfusion studies within the past 12 months
- more than 2 CT angiograms within the past 12 months
- concurrent enrollment in a clinical trial judged by the investigator to introduce concerns about safety or confounding
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
Coorti e interventi
Gruppo / Coorte |
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Healthy control subjects
Healthy control subjects matched to psoriasis patients on traditional cardiovascular risk factors will be studied at baseline.
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Psoriasis patients starting etanercept
Patients with moderate to severe psoriasis with or without arthritis who are about to be started on etanercept (enbrel) by their treating clinicians will be studied at baseline and 3 months after etanercept therapy.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET.
Lasso di tempo: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Degree of aortic/coronary atherosclerotic plaque inflammation assessed via cardiac FDG-PET as target to background ratio (TBR) of the standardized uptake value (SUV).
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Aortic/coronary atherosclerotic plaque burden on MDCT coronary angiography.
Lasso di tempo: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Burden of aortic/coronary atherosclerotic plaque as measured by MDCT coronary angiography.
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Aortic/coronary atherosclerotic plaque morphology on MDCT coronary angiography.
Lasso di tempo: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Morphology of the aortic/coronary atherosclerotic plaque (e.g.
calcification score, vulnerability characteristics) as measured by MDCT coronary angiography.
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Endothelial function as measured by flow-mediated vasodilation.
Lasso di tempo: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Oral glucose tolerance.
Lasso di tempo: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Blood sugar and insulin levels during a standard 2-hour oral glucose tolerance test.
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Lipid and lipoprotein levels.
Lasso di tempo: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Levels of total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, apolipoprotein A1, apolipoprotein B, apolipoprotein C-II, apolipoprotein C-III, and apolipoprotein E.
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Inflammatory biomarker levels.
Lasso di tempo: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Levels of inflammatory biomarkers including but not limited to high-sensitivity C-reactive protein, interleukin-6, and TNF-alpha.
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Body fat distribution.
Lasso di tempo: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Measurements of height, weight, waist-to-hip ratio, leg circumference, arm circumference, and neck circumference.
Determinations by whole body DEXA scanning of the total body and regional percent fat and lean body mass.
Determination by single-slice abdominal computed tomography of total fat area, visceral adipose tissue, and subcutaneous adipose tissue.
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Steven K Grinspoon, MD, Massachusetts General Hospital
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 febbraio 2012
Completamento primario (Effettivo)
1 gennaio 2016
Completamento dello studio (Effettivo)
1 gennaio 2016
Date di iscrizione allo studio
Primo inviato
29 dicembre 2011
Primo inviato che soddisfa i criteri di controllo qualità
30 gennaio 2012
Primo Inserito (Stima)
1 febbraio 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 marzo 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 marzo 2017
Ultimo verificato
1 marzo 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2011P-000557
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 .