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

Main Article Content

Bruno Laurenti Janella
https://orcid.org/0000-0003-1230-4653
Camila Naomi Matsuda
https://orcid.org/0000-0003-3749-0691
Rafael Daher Pereira
https://orcid.org/0000-0002-3483-0198
Jean Michel Magalhães
Marcilene Aparecida da Silva

Abstract

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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1.
Janella BL, Matsuda CN, Pereira RD, Magalhães JM, Silva MA da. 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. HSJ [Internet]. 2021 Mar. 13 [cited 2024 Nov. 21];11(1):61-8. Available from: https://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/article/view/1047
Section
ORIGINAL ARTICLE
Author Biographies

Bruno Laurenti Janella, Itajubá Clinics Hospital, Faculty of Medicine of Itajubá

Coordinator of the Interventional Cardiology Service at Hospital de Clínicas de Itajubá. Professor of the Discipline of Introduction to Minimally Invasive Procedures at the Faculty of Medicine of Itajubá. Master in Health Sciences from the Israeli Institute of Education and Research Albert Einstein (2016).

Camila Naomi Matsuda, Itajubá Clinics Hospital

Interventionist cardiologist at Hospital de Clínicas de Itajubá.

Rafael Daher Pereira, Faculty of Medicine of Itajubá

Sicth-year medical student of the Faculty of Medicine of Itajubá.

Jean Michel Magalhães, Faculty of Medicine of Itajubá

Sixth-year medical stuent at the Faculty of Medicine of Itajubá.

Marcilene Aparecida da Silva, Itajubá Clinics Hospital

Lead Nurse of the Interventional Cardiologist Sector at Hospital de Clínicas de Itajubá.

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