title: Efficacy of intravenous nicorandil for fractional flow reserve assessment: study protocol for a crossover randomised trial.
abstract: Nicorandil 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.
  
  
  
  This 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.
  
  
  
  The protocol was approved by the Institutional Review Board at Chiba University Hospital. Study findings will be published in peer-reviewed journals.
  
  
  
  UMIN000019309; Pre-results.
authors.affiliation: Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Nishi
authors.affiliation: Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Kitahara
authors.affiliation: Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
authors.forename: Yoshihide
authors.initials: Y
authors.lastname: Fujimoto
authors.affiliation: Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Nakayama
authors.affiliation: Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Sugimoto
authors.affiliation: Department of Global Clinical Research, Chiba University Graduate School of Medicine, Chiba, Japan.
authors.forename: Kengo
authors.identifier: 0000-0003-4529-9045
authors.initials: K
authors.lastname: Nagashima
authors.affiliation: Clinical Research Centre, University Hospital, Chiba University School of Medicine, Chiba, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Hanaoka
authors.affiliation: Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Kobayashi
mesh_terms: D000241:Adenosine / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000188:drug therapy*; D003331:Coronary Vessels / Q000503:physiopathology; D018592:Cross-Over Studies; D005260:Female; D053805:Fractional Flow Reserve, Myocardial / Q000187:drug effects*; D006439:Hemodynamics; D006801:Humans; D007262:Infusions, Intravenous; D007564:Japan; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D020108:Nicorandil / Q000008:administration & dosage*; D011446:Prospective Studies; D012107:Research Design; D016037:Single-Blind Method; D014665:Vasodilator Agents / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D014665:Vasodilator Agents; D020108:Nicorandil; D000241:Adenosine