Myocardial Transfection of Hypoxia Inducible Factor-1.ALPHA. via an Adenoviral Vector During Coronary Artery Bypass Grafting - A Multicenter Phase I and Safety Study -
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- Kilian Eckehard Gerd
- Department of Cardiac Surgery, University of Munich
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- Sadoni Sebastian
- Department of Cardiac Surgery, University of Munich
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- Vicol Calin
- Department of Cardiac Surgery, University of Munich
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- Kelly Ralph
- Genzyme, Europe BV
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- Hulst Karen van
- Genzyme, Europe BV
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- Schwaiger Markus
- Department of Nuclear Medicine, University of Munich
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- Kupatt Christian
- Department of Cardiology, University of Munich
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- Boekstegers Peter
- Department of Cardiology, University of Munich
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- Pillai Ravi
- Department of Cardiothoracic Surgery, John Radcliffe Hospital
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- Channon Keith
- Department of Cardiovascular Medicine, John Radcliffe Hospital
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- Hetzer Roland
- German Heart Centre Berlin, Department of Cardiothoracic and Vascular Surgery
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- Reichart Bruno
- Department of Cardiac Surgery, University of Munich
書誌事項
- タイトル別名
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- – A Multicenter Phase I and Safety Study –
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Background: Increasing numbers of patients with advanced coronary artery disease have limited options for percutaneous and/or surgical revascularization. A prospective, randomized, phase I clinical multicenter trial was performed to assess the feasibility and safety of delivering a pro-angiogenic transcription factor termed "hypoxia inducible factor-1α", delivered to ischemic cardiac muscle via a type 2 adenoviral (Ad2HIF) vector. Methods and Results: The 13 patients were included under the following criteria: 1 hypoperfused area of viable ventricular muscle without options for revascularization and left ventricular ejection fraction ≥30%. After coronary artery bypass grafting was completed, 10 injections of the study drug (n=10), in 3 escalating doses up to 1×1011 viral particles or saline (n=3) as a placebo control, were injected intramyocardially. After completion of the 1-year follow-up, all patients had uncomplicated postoperative courses, are alive and feeling well; 1 patient had a self-limited run of tachycardia postoperatively and at 6 months, 1 patient developed recurrent angina. Positron emission tomography perfusion analysis revealed improvement in the Ad2HIF injected areas in selected patients. Conclusions: These data support the feasibility and preliminary safety of adenoviral transfection with Ad2HIF in regions of viable myocardium. Additional studies will be required to determine the efficacy and safety of Ad2HIF. (Circ J 2010; 74: 916 - 924)<br>
収録刊行物
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- Circulation Journal
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Circulation Journal 74 (5), 916-924, 2010
一般社団法人 日本循環器学会
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詳細情報 詳細情報について
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- CRID
- 1390001205102806272
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- NII論文ID
- 10026473576
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- NII書誌ID
- AA11591968
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- ISSN
- 13474820
- 13469843
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- 本文言語コード
- en
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- データソース種別
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- JaLC
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- CiNii Articles
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