Patent Foramen Ovale and Cryptogenic Stroke

the PC-trial in Brazil and around the world

Authors

  • Marcia Maiumi Fukujima Neurologista, doutora, Disciplina de Medicina de Urgência da Universidade Federal de São Paulo (UNIFESP), investigadora do PC-trial
  • Célia Maria Camelo Silva Cardiologista, doutora, Disciplina de Cardiologia, UNIFESP, investigadora do PC-trial
  • Carlos Eduardo Bernini Kapins Especializando em Cardiologia Infantil, Disciplina de Cardiologia, UNIFESP, colaborador do PC-trial
  • Antonio Carlos Carvalho Cardiologista, Professor Titular, Chefe da Disciplina de Cardiologia, UNIFESP, investigador do PC-trial
  • PC trial Study Group

DOI:

https://doi.org/10.34024/rnc.2006.v14.8758

Keywords:

patent foramen ovale, stroke, clinical trial

Abstract

Introduction: Several studies have shown an association between cryptogenic stroke and embolism from patent foramen ovale (PFO) but the question how to prevent further events is unresolved. PC-trial is a randomized clinical trial comparing the efficacy of percutaneous closure of PFO with medical treatment in patients with cryptogenic embolism, and is going on. The objective of this manuscript is to describe the localization of the centers and the number of patients included. Methods: In PC-Trial the percutaneous closure of the PFO using the Amplatzer PFO occluder is compared with best medical treatment in patients with cryptogenic stroke. Randomization is stratified according to patients age (18-45 versus 45-60 years), presence of atrial septal aneurysm, and number of embolic events before randomization. Primary endpoints are death, nonfatal stroke and peripheral embolism. Results: Recruitment started with 20 patients in 2000. Thirty-two centers of 11 countries had ethical approval from local committee. Twenty-seven centers are actively randomizing patients. Up to now 278 patients entered the study. Discussion: The answer about the best treatment for PFO will only be possible after conclusion of ongoing clinical trials. PC-trial is the unique trial that includes a Brazilian center.

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Author Biography

PC trial Study Group

Investigadores Principais:

Meier B, Matle H, do Inselspital, Berna. Administração do ensaio: InterCorNet Clinical Research Center, Zurich. Investigadores por país. Austrália: Walton T, Frayne J, Menaham S, Hockings B. Áustria: Probst P, Baumgartner H, Lalouschek W. Bélgica: Muyldermans L, Vanhooren G. Canadá: Ibrahim R, Lanthier S. Dinamarca: Emmertsen K, Andersen G, Kristensen B. Alemanha: Fassbender D, Hambrecht R, Maisch B, Funck R, Schanzenbächer P, Müllges W, Böhm M, Hennen B, Becker G, Conze M, Klotz JM, Teupe C, Steinmetz H, Schräder R, Hauptmann K, Gehrig T, Reek S, Görtler M, Seggewiss H, Mühler J, Waas W, Jauss M. Polônia: Dudek D, Bartus S, Szczudlik A. República Eslovaca: Fridrich V, Garay R. Suíça: Meier B, Matle H, Windecker S. Reino Unido: Hildick-Smith D, Northridge D, Weller B, Leatham EW, MCKenna W, Markus H.

References

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Chatterjee T, Aeschbacher B, Meier B.Non-surgical closure of secundum atrial septal defect and patent foramen ovale. Schweiz Med Wochenschr 1997; 127:2054-2060.

Messé SR, Silverman IE, Kizer JR, Homma S, Zahn C, Gronseth G, et al. Practice Parameter: Recurrent stroke with patent foramen ovale and atrial AGRADECIMENTOS

Sigma Pharma pelo apoio financeiro. Prof. Dr. Juarez Ortiz, Dra. Cláudia Gianini Mônaco e Dr. Luiz Darcy Ferreira, do Centro de Cardiologia Não-Invasiva - OMNI Serviços Diagnósticos, pela realização dos ecocardiogramas transesofágicos iniciais. Cardiologistas na UNIFESP: Dra. Solange Bernardes Tatani e Dr. Valdinai Pereira. Equipe do Pronto Socorro de Neurologia Hospital São Paulo/UNIFESP: Prof. Dr. Gilmar Fernandes do Prado, Dra. Maria Elisabeth Matta de Rezende Ferraz, Enedina Maria Lobato de Oliveira, Sílvio Francisco, Nilton Amorim Souza, Fernando Nakandakare, Ivanilson Alves de Oliveira e Dr. Evando Penteado Villar Félix. Equipe de Fisioterapia pelas avaliações e suporte aos pacientes: Dra. Sissy Veloso Fontes, Rita de Cássia dos Reis Moura, Marcelo Reina Siliano, Simone Ribas Ghezzi, Fernando

Ida e Ébe Monteiro. septal aneurysm: Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2004; 62:1042-1050.

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embolism using the amplatzer PFO occluder: initial and intermediate-term results of the U.S. multicenter clinical trial. Catheter Cardiovasc Interv 2003; 60:524-528

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Topcuoglu MA, Mattle HP, Meier B, Windecker S, Messé SR, Homma S, et al. Practice Parameter: Recurrent stroke with patent foramen ovale and atrial septal aneurysm: Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2004; 63:2198-2199

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Published

2006-06-30

How to Cite

Fukujima, M. M., Silva, C. M. C., Kapins, C. E. B., Carvalho, A. C., & Group, P. trial S. (2006). Patent Foramen Ovale and Cryptogenic Stroke: the PC-trial in Brazil and around the world. Revista Neurociências, 14(2), 14–16. https://doi.org/10.34024/rnc.2006.v14.8758

Issue

Vol. 14 No. 2 (2006)

Section

Artigos Originais
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##plugins.generic.dates.published## 2006-06-30

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