Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study (MMAPPS)
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET.
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Aortic/coronary atherosclerotic plaque burden on MDCT coronary angiography.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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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協力者と研究者
捜査官
- 主任研究者:Steven K Grinspoon, MD、Massachusetts General Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2011P-000557
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