Efficacy of intravenous nicorandil for fractional flow reserve assessment: study protocol for a crossover randomised trial

Abstract

IntroductionNicorandil has vasodilatory effects on both the epicardial coronary arteries and the coronary microvasculature, thereby increasing coronary blood flow. Intravenous administration of nicorandil can be applicable for fractional flow reserve (FFR) measurement as a hyperaemic agent and a possible alternative to adenosine. However, the effectiveness of intravenous nicorandil infusion for FFR measurement is largely unclear.Methods and analysisThis crossover randomised study is being performed to investigate the efficacy of intravenous administration of nicorandil for FFR measurement. Patients with an intermediate coronary artery stenosis who satisfy the eligibility criteria undergo FFR measurement with a consecutive randomised order of patient-blind infusions of continuous intravenous administration of adenosine and a single bolus intravenous administration of nicorandil. The primary end point of the study is the agreement between the FFR values obtained by the intravenous nicorandil and those obtained by the intravenous adenosine. Recruitment of this trial started in November 2015 and will end in March 2017, or until a total of 50 participants have been recruited.Ethics and disseminationThe protocol was approved by the Institutional Review Board at Chiba University Hospital. Study findings will be published in peer-reviewed journals.Trial registration numberUMIN000019309; Pre-results.

Effect of Nicorandil Administration on Preventing Contrast-Induced Nephropathy: A Meta-Analysis

“…Nicorandil is a hybrid antianginal and potassium (K) channel (K-ATP channel) opener 6 that reduces myocardial injury and improves coronary hemodynamic parameters. 7 Currently, the European Society of Cardiology guidelines recommend the use of nicorandil for the management of stable coronary artery disease.…”