Effect of remote ischemic preconditioning on electrophysiological and biomolecular parameters in nonvalvular paroxysmal atrial fibrillation (RIPPAF study): Rationale and study design of a randomized, controlled clinical trial

Abstract

Remote ischemic preconditioning (RIPC) has been studied in models of different cardiovascular entities. Recently, a beneficial effect of RIPC on incidence of atrial fibrillation (AF) in postsurgical patients has been suggested. However, the potential impact of RIPC on electrophysiological- and thrombogenesis-related parameters in the setting of paroxysmal nonvalvular AF has not been investigated. The aim of the study is to answer the following questions: (1) Does RIPC have impact on inducibility of AF in patients with known paroxysmal AF? If yes, what are the direct electrophysiological mechanisms of this phenomenon, and could RIPC be implemented to reduce AF burden? (2) Does RIPC have the potential to minimize thrombogenic effects of simulated episodes of AF? If so, what are inhibited components of thrombogenesis and can this be used to reduce thromboembolic risk related to paroxysmal AF? The presented study is a 2-arm, randomized, placebo-controlled, double-blinded, single-center trial in a cohort of 146 patients with paroxysmal AF referred for AF ablation in sinus rhythm. The study will collect electrophysiological data such as variability of P-wave morphology, atrial refractory period, conduction times, and inducibility/sustainability of AF. Furthermore, AF-induced prothrombotic processes will be analyzed by quantification of platelet aggregates, analysis of platelet function, and measurement of thrombogenesis-related plasma markers. Moreover, the study will provide a unique bio-database for further analysis of molecular and genetic mechanisms responsible for observed results.