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Title: Design of a clinical trial for the assessment cardioversion using Transesophageal Echocardiography (The ACUTE Multicenter Study)
Authors: Stoddard, M. F.
Longaker, R.
Klein, A. L.
Vaughn, S.
Porter, T. R.
Silver, M.
Chartrand, M.
Smith, R. H.
Lazar, J.
Bilodeau, S.
Trehan, N.
Kasliwal, R. R.
Singh, S.
Acquatella, H.
Benitez, J.
Mendoza, I
Mathias Junior, Wilson [UNIFESP]
Borowski, Luciana Pires [UNIFESP]
Small, R. S.
Soucier, D. J.
Hollywood, L.
Erbel, R.
Muller, S.
Madkour, M. A.
Melman, P.
Pasteuning, W. H.
Katz, W. E.
Obarski, T. P.
Mayer, C.
Eichelberger, J. P.
Opladen, J.
Redberg, R. F.
Bosco, V
Pape, L. A.
Aurigemma, G.
Rofino, K. A.
Barbosa, M. M.
Fattal, P. G.
Harris, M.
Blanchard, D. G.
Sobel, J.
Schwartz, S. L.
Garcia, M. J.
Henck, T.
Hoit, B. D.
Kraft, L.
Baruch, L.
Patacsil, P.
Arrowood, J. A.
Nixon, J. V.
Shapiro, S. M.
Wang, S. J.
Mele, D.
Gruppioni, G.
Lang, R. M.
Spencer, K.
Furlong, K.
Grayburn, P. A.
Abraham, T.
Black, I. W.
Smith, A.
Walsh, W.
Davidson, T.
Rosen, S. E.
Chepurko, L.
Figueredo, E.
Quinones, M. A.
Wilansky, S.
Harlan, M.
Shively, B. K.
Gelgand, E.
Haichin, R.
Feldman, B. T.
Rodgers, G. P.
Ducote, V
Orsinelli, D. A.
Sagar, K. B.
Bambulas, D.
Coulis, L.
Sommers, T.
Langholz, D.
Johnson, E.
Phillips, P. L.
Wahl, S. A.
Nagelhout, D.
Farley, R.
Miller, K.
Nye, G. C.
Barackman, K.
Pai, R. G.
Daggubatti, R.
Tyler, D.
Briller, J.
McNally, B.
Pollack, P. S.
Whitley, D.
Lengyel, M.
Kancz, S.
Davidoff, R.
Manning, W. J.
Mansur, J.
Carneiro, M.
Sorrell, V. L.
Corbett, C.
Gillam, L. D.
Mangion, J.
Fisher, M.
Schlesinger, R. B.
Palazzo, D.
LaVoie, J.
Krasnow, N.
Sherrid, M.
Tan, E.
Abi-Samra, M.
Grant, A.
Khalighi, K.
Mezei, L. E.
Hamilton, W. P.
Riggio, S.
Markarian, M.
Ring, M.
Fein, S.
Megas-Nowak, I
Goldberger, M. H.
Wilson, D. B.
DeVore, D.
Weiss, R. J.
Chandler, D.
Arheart, K. L.
Grimm, R. A.
Murray, R. D.
Chung, M. K.
Vaughn, S. E.
Becker, E. R.
Culler, S. D.
Ellis, S. G.
Elson, P. J.
Olin, J.
Furlan, A. J.
Lauer, M.
Asinger, R. W.
Halperin, J. L.
Steering Publications Comm ACUTE Study ACUTE I
Cleveland Clin Fdn
Univ Louisville
Univ Nebraska
Winthrop Univ Hosp
Escorts Heart Inst & Res Ctr
Ctr Med Caracas
Universidade Federal de São Paulo (UNIFESP)
Lancaster Heart Fdn
Univ Essen Gesamthsch
El Azhar Univ
St Elisabeth Hosp
Univ Pittsburgh
Riverside Methodist Hosp
Univ Rochester
Univ Calif San Francisco
Univ Massachusetts
Hosp Vera Cruz
Hosp Socor
Saginaw Heart Grp
Univ Calif San Diego
New England Med Ctr
White River Junction VA Med Ctr
Univ Cincinnati
Vet Affairs Med Ctr
Virginia Commonwealth Univ
Harbor UCLA Med Ctr
Osped Civile
Univ Chicago
Univ Texas
Manly Hosp
Prince Henry Hosp
N Shore Univ Hosp
Baylor Coll Med
Texas Heart Inst
Univ New Mexico
Royal Victoria Hosp
Columbia Cardiovasc Clin
Austin Heart
Ohio State Univ
Med Coll Wisconsin
St Nicholas Hosp
Blodgett Mem Med Ctr
Clearwater Cardiovasc Consultants
N Cent Heart Fdn
Sentara Norfolk Gen Hosp
Loma Linda VA Med Ctr
MacNeal Ctr Clin Res
Temple Univ Hosp
Hungarian Inst Cardiol
Boston Univ
Beth Israel Hosp
Hosp Servidores Estado
E Carolina Univ
Hartford Hosp
Grad Hosp Philadelphia
St Lukes Roosevelt Hosp
Alton Ochsner Med Fdn & Ochsner Clin
Easton Hosp
St Johns Mercy Med Ctr
Michigan Capital Med Ctr
Albany Med Coll
Montefiore Med Ctr
Univ Kansas
Androscoggin Cardiol Associates
Emory Univ
Issue Date: 1-Apr-1998
Publisher: Excerpta Medica Inc
Citation: American Journal Of Cardiology. New York: Excerpta Medica Inc, v. 81, n. 7, p. 877-883, 1998.
Abstract: Patients with atrial fibrillation (AF) undergoing cardioversion are at an increased risk of cardioembolic stroke and require anticoagulation, The Assessment of Cardioversion Using Transesophageal Echocardiography (ACUTE) Multicenter Study is a randomized clinical trial of patients undergoing electrical cardioversion of AF of >2 days' duration comparing a transesophageal-guided strategy (TEE) with brief anticoagulation to the conventional anticoagulation strategy. patients randomly assigned to the TEE-guided strategy receive therapeutic anticoagulation before TEE and cardioversion, followed by 4 weeks of anticoagulation, Patients with thrombus imaged by TEE have postponement of cardioversion, continue anticoagulation for 3 weeks, and undergo a repeat TEE, Conventional strategy patients receive 3 weeks of anticoagulation before cardioversion, followed by 4 weeks of anticoagulation after cardioversion, The primary end point events are ischemic stroke, transient ischemic attack, and systemic embolization for an 8-week period from enrollment, Secondary end points are major and minor bleeding, all-cause mortality, successful return to and maintenance of sinus rhythm, and cost effectiveness, Analysis is based on the intention-to-treat principle. The anticipated rates of embolism of 2.9% for conventional strategy and 1.2% for the TEE-guided strategy are based on published research and the completed pilot study, The ACUTE Multicenter Study will randomize therapy and follow an estimated 3,000 patients from 65 study sites to determine the relative efficacy of the TEE-guided and conventional approaches to electrical cardioversion for patients in AF, The results of this investigation will have important clinical implications for the management of patients with AF undergoing electrical cardioversion. (C) 1998 by Excerpta Medica, Inc.
ISSN: 0002-9149
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