Double-blind, single-center, randomized study evaluating the effectiveness of Isosorbide Mononitrate in preventing radial artery occlusion compared to placebo in patients undergoing elective percutaneous coronary procedure: study protocol

Detalhes bibliográficos
Autor(a) principal: Janella, Bruno Laurenti
Data de Publicação: 2021
Outros Autores: Matsuda, Camila Naomi, Pereira, Rafael Daher, Magalhães, Jean Michel, Silva, Marcilene Aparecida da
Tipo de documento: Artigo
Idioma: por
eng
Título da fonte: Revista Ciências em Saúde
Texto Completo: https://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/article/view/1047
Resumo: Objectives: The primary objective of this study will be to evaluate the efficacy of subcutaneous and peri-arterial isosorbide mononitrate in preventing occlusion of the radial artery (ORA) after percutaneous coronary procedures (PCP) performed by the transradial approach (TRA). As secondary objectives, define the incidence of ORA in the institution and assess variables related to the risk of occlusion. Methods: Single-center, double-blind, randomized study, including in- and outpatients from a high complexity hospital, admitted to performing PCP, diagnostic or therapeutic, by TRA, in stable coronary conditions (elective) or acute coronary syndrome. The sample will be randomly divided into a group that will receive the medication and a control group. All participants will be submitted to palpatory assessment of radial artery patency and the Barbeau inverse test within 24 h and seven days after the procedure. This will be the first study to evaluate isosorbide mononitrate as an accessible and inexpensive pharmacological method for preventing OAR after PCP by VTR.
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spelling Double-blind, single-center, randomized study evaluating the effectiveness of Isosorbide Mononitrate in preventing radial artery occlusion compared to placebo in patients undergoing elective percutaneous coronary procedure: study protocolEstudo duplo-cego, unicêntrico, randomizado, avaliando a eficácia o mononitrato de isossorbida na prevenção da oclusão de artéria radial comparado ao placebo em pacientes submetidos a procedimento coronariano percutâneo eletivo: protocolo de estudoisosorbideradial arterypercutaneous coronary interventionisossorbidaartéria radialintervenção coronária percutâneaObjectives: The primary objective of this study will be to evaluate the efficacy of subcutaneous and peri-arterial isosorbide mononitrate in preventing occlusion of the radial artery (ORA) after percutaneous coronary procedures (PCP) performed by the transradial approach (TRA). As secondary objectives, define the incidence of ORA in the institution and assess variables related to the risk of occlusion. Methods: Single-center, double-blind, randomized study, including in- and outpatients from a high complexity hospital, admitted to performing PCP, diagnostic or therapeutic, by TRA, in stable coronary conditions (elective) or acute coronary syndrome. The sample will be randomly divided into a group that will receive the medication and a control group. All participants will be submitted to palpatory assessment of radial artery patency and the Barbeau inverse test within 24 h and seven days after the procedure. This will be the first study to evaluate isosorbide mononitrate as an accessible and inexpensive pharmacological method for preventing OAR after PCP by VTR.Objetivos: O objetivo primário deste estudo será avaliar a eficácia do mononitrato de isossorbida subcutâneo e peri-arterial na prevenção da oclusão da artéria radial (OAR) após procedimento coronariano percutâneo (PCP) realizado pela via transradial (VTR). Como objetivos secundários, definir a incidência de OAR em no serviço assim como avaliar variáveis relacionadas ao risco de oclusão.Métodos: Estudo unicêntrico, duplo-cego, randomizado, onde serão incluídos pacientes internados e eletivos de hospital de alta complexidade, que derem entrada para a realização de PCP, diagnóstico ou terapêutico, por VTR, em quadros coronarianos estáveis (eletivos) ou em síndromes coronarianas agudas. A amostra será dividida de forma randômica em grupo que receberá a medicação e um grupo controle. Todos os participantes serão submetidos a avaliação palpatória da patência da artéria radial e pelo teste inverso de Barbeau nas 24 horas e sete dias após o procedimento. Este será o primeiro estudo a avaliar o mononitrato de isossorbida como método farmacológico acessível e barato para prevenção da OAR após PCP por VTR.AISI/HCI2021-03-13info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionPeer reviewedAvaliado pelos parestextoinfo:eu-repo/semantics/otherapplication/pdfapplication/pdftext/xmltext/htmlhttps://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/article/view/104710.21876/rcshci.v11i1.1047Revista Ciências em Saúde; v. 11 n. 1 (2021): Janeiro a Março de 2021; 61-68Health Sciences Journal; Vol 11 No 1 (2021): January to March 2021; 61-682236-378510.21876/rcshci.v11i1reponame:Revista Ciências em Saúdeinstname:Hospital de Clínicas de Itajubáinstacron:HCIporenghttps://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/article/view/1047/677https://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/article/view/1047/678https://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/article/view/1047/696https://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/article/view/1047/697Copyright (c) 2021 Revista Ciências em Saúdehttps://creativecommons.org/licenses/by-nc-sa/4.0info:eu-repo/semantics/openAccess Janella, Bruno LaurentiMatsuda, Camila NaomiPereira, Rafael DaherMagalhães, Jean MichelSilva, Marcilene Aparecida da2021-03-27T16:17:05Zoai:ojs.portalrcs.hcitajuba.org.br:article/1047Revistahttps://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zeroPUBhttps://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/oaircs@hcitajuba.org.br||rcsfmit@medicinaitajuba.com.br2236-37852236-3785opendoar:2021-03-27T16:17:05Revista Ciências em Saúde - Hospital de Clínicas de Itajubáfalse
dc.title.none.fl_str_mv Double-blind, single-center, randomized study evaluating the effectiveness of Isosorbide Mononitrate in preventing radial artery occlusion compared to placebo in patients undergoing elective percutaneous coronary procedure: study protocol
Estudo duplo-cego, unicêntrico, randomizado, avaliando a eficácia o mononitrato de isossorbida na prevenção da oclusão de artéria radial comparado ao placebo em pacientes submetidos a procedimento coronariano percutâneo eletivo: protocolo de estudo
title Double-blind, single-center, randomized study evaluating the effectiveness of Isosorbide Mononitrate in preventing radial artery occlusion compared to placebo in patients undergoing elective percutaneous coronary procedure: study protocol
spellingShingle Double-blind, single-center, randomized study evaluating the effectiveness of Isosorbide Mononitrate in preventing radial artery occlusion compared to placebo in patients undergoing elective percutaneous coronary procedure: study protocol
Janella, Bruno Laurenti
isosorbide
radial artery
percutaneous coronary intervention
isossorbida
artéria radial
intervenção coronária percutânea
title_short Double-blind, single-center, randomized study evaluating the effectiveness of Isosorbide Mononitrate in preventing radial artery occlusion compared to placebo in patients undergoing elective percutaneous coronary procedure: study protocol
title_full Double-blind, single-center, randomized study evaluating the effectiveness of Isosorbide Mononitrate in preventing radial artery occlusion compared to placebo in patients undergoing elective percutaneous coronary procedure: study protocol
title_fullStr Double-blind, single-center, randomized study evaluating the effectiveness of Isosorbide Mononitrate in preventing radial artery occlusion compared to placebo in patients undergoing elective percutaneous coronary procedure: study protocol
title_full_unstemmed Double-blind, single-center, randomized study evaluating the effectiveness of Isosorbide Mononitrate in preventing radial artery occlusion compared to placebo in patients undergoing elective percutaneous coronary procedure: study protocol
title_sort Double-blind, single-center, randomized study evaluating the effectiveness of Isosorbide Mononitrate in preventing radial artery occlusion compared to placebo in patients undergoing elective percutaneous coronary procedure: study protocol
author Janella, Bruno Laurenti
author_facet Janella, Bruno Laurenti
Matsuda, Camila Naomi
Pereira, Rafael Daher
Magalhães, Jean Michel
Silva, Marcilene Aparecida da
author_role author
author2 Matsuda, Camila Naomi
Pereira, Rafael Daher
Magalhães, Jean Michel
Silva, Marcilene Aparecida da
author2_role author
author
author
author
dc.contributor.author.fl_str_mv Janella, Bruno Laurenti
Matsuda, Camila Naomi
Pereira, Rafael Daher
Magalhães, Jean Michel
Silva, Marcilene Aparecida da
dc.subject.por.fl_str_mv isosorbide
radial artery
percutaneous coronary intervention
isossorbida
artéria radial
intervenção coronária percutânea
topic isosorbide
radial artery
percutaneous coronary intervention
isossorbida
artéria radial
intervenção coronária percutânea
description Objectives: The primary objective of this study will be to evaluate the efficacy of subcutaneous and peri-arterial isosorbide mononitrate in preventing occlusion of the radial artery (ORA) after percutaneous coronary procedures (PCP) performed by the transradial approach (TRA). As secondary objectives, define the incidence of ORA in the institution and assess variables related to the risk of occlusion. Methods: Single-center, double-blind, randomized study, including in- and outpatients from a high complexity hospital, admitted to performing PCP, diagnostic or therapeutic, by TRA, in stable coronary conditions (elective) or acute coronary syndrome. The sample will be randomly divided into a group that will receive the medication and a control group. All participants will be submitted to palpatory assessment of radial artery patency and the Barbeau inverse test within 24 h and seven days after the procedure. This will be the first study to evaluate isosorbide mononitrate as an accessible and inexpensive pharmacological method for preventing OAR after PCP by VTR.
publishDate 2021
dc.date.none.fl_str_mv 2021-03-13
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
Peer reviewed
Avaliado pelos pares
texto
info:eu-repo/semantics/other
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/article/view/1047
10.21876/rcshci.v11i1.1047
url https://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/article/view/1047
identifier_str_mv 10.21876/rcshci.v11i1.1047
dc.language.iso.fl_str_mv por
eng
language por
eng
dc.relation.none.fl_str_mv https://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/article/view/1047/677
https://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/article/view/1047/678
https://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/article/view/1047/696
https://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/article/view/1047/697
dc.rights.driver.fl_str_mv Copyright (c) 2021 Revista Ciências em Saúde
https://creativecommons.org/licenses/by-nc-sa/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2021 Revista Ciências em Saúde
https://creativecommons.org/licenses/by-nc-sa/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
text/xml
text/html
dc.publisher.none.fl_str_mv AISI/HCI
publisher.none.fl_str_mv AISI/HCI
dc.source.none.fl_str_mv Revista Ciências em Saúde; v. 11 n. 1 (2021): Janeiro a Março de 2021; 61-68
Health Sciences Journal; Vol 11 No 1 (2021): January to March 2021; 61-68
2236-3785
10.21876/rcshci.v11i1
reponame:Revista Ciências em Saúde
instname:Hospital de Clínicas de Itajubá
instacron:HCI
instname_str Hospital de Clínicas de Itajubá
instacron_str HCI
institution HCI
reponame_str Revista Ciências em Saúde
collection Revista Ciências em Saúde
repository.name.fl_str_mv Revista Ciências em Saúde - Hospital de Clínicas de Itajubá
repository.mail.fl_str_mv rcs@hcitajuba.org.br||rcsfmit@medicinaitajuba.com.br
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