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

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.