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(Circulation. 2000;102:e73.)
© 2000 American Heart Association, Inc.

Current Perspective

Clinical Trials in Coronary Angiogenesis: Issues, Problems, Consensus

An Expert Panel Summary

Michael Simons, MD; Robert O. Bonow, MD; Nicolas A. Chronos, MD; David J. Cohen, MD, MSc; Frank J. Giordano, MD; H. Kirk Hammond, MD; Roger J. Laham, MD; William Li, MD; Marylin Pike, MD; Frank W. Sellke, MD; Thomas J. Stegmann, MD; James E. Udelson, MD; Todd K. Rosengart, MD

From the Angiogenesis Research Center (M.S., R.J.L., F.W.S.), Interventional Cardiology (D.J.C., R.J.L.) and Division of Cardiothoracic Surgery (F.W.S.), BIDMC, Harvard Medical School, Boston, Mass; Division of Cardiology, Northwestern University School of Medicine (R.O.B.), Chicago, Ill; Atlanta Cardiology (N.A.C.), Atlanta, Ga; Division of Cardiology, Yale University School of Medicine (F.J.G.), New Haven, Conn; VA Medical Center and University of California-San Diego (H.K.H.), San Diego, Calif; The Angiogenesis Foundation (W.L.), Cambridge, Mass; Chiron Corporation (M.P.), Sunnyvale, Calif; Department of Thoracic and Cardiovascular Surgery, Fulda Hospital (T.J.S.), Fulda, Germany; Division of Cardiology, New England Medical Center and Tufts University School of Medicine (J.E.U.), Boston, Mass; and Division of Cardiothoracic Surgery, Evanston Hospital, Northwestern University (T.K.R.), Chicago, Ill.

Correspondence to Michael Simons, MD, Angiogenesis Research Center, SL-423, BIDMC, 330 Brookline Ave, Boston, MA 02215. E-mail msimons{at}caregroup.harvard.edu

Abstract—The rapid development of angiogenic growth factor therapy for patients with advanced ischemic heart disease over the last 5 years offers hope of a new treatment strategy based on generation of new blood supply in the diseased heart. However, as the field of therapeutic coronary angiogenesis is maturing from basic and preclinical investigations to clinical trials, many new and presently unresolved issues are coming into focus. These include in-depth understanding of the biology of angiogenesis, selection of appropriate patient populations for clinical trials, choice of therapeutic end points and means of their assessment, choice of therapeutic strategy (gene versus protein delivery), route of administration, and the side effect profile. The present article presents a summary statement of a panel of experts actively working in the field, convened by the Angiogenesis Foundation and the Angiogenesis Research Center during the 72nd meeting of the American Heart Association to define and achieve a consensus on the challenges facing development of therapeutic angiogenesis for coronary disease.

Key Words: angiogenesis • coronary disease • growth substances • revascularization • clinical trials

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