Rationale and Design of the Groningen Intervention Study for the Preservation of Cardiac Function with Sodium Thiosulfate after St-segment Elevation Myocardial Infarction (GIPS-IV) trial
Marie-Sophie Ly de Koning, Paulien van Dorp, Solmaz Assa, Minke Ht Hartman, Michiel Voskuil, Rutger L Anthonio, Duco Veen, Gabija Pundziute-Do Prado, Tim Leiner, Harry van Goor, Peter van der Meer, Dirk J van Veldhuisen, Robin Nijveldt, Erik Lipsic, Pim van der Harst, Marie-Sophie Ly de Koning, Paulien van Dorp, Solmaz Assa, Minke Ht Hartman, Michiel Voskuil, Rutger L Anthonio, Duco Veen, Gabija Pundziute-Do Prado, Tim Leiner, Harry van Goor, Peter van der Meer, Dirk J van Veldhuisen, Robin Nijveldt, Erik Lipsic, Pim van der Harst
Abstract
Background: Ischemia and subsequent reperfusion cause myocardial injury in patients presenting with ST-segment elevation myocardial infarction (STEMI). Hydrogen sulfide (H2S) reduces "ischemia-reperfusion injury" in various experimental animal models, but has not been evaluated in humans. This trial will examine the efficacy and safety of the H2S-donor sodium thiosulfate (STS) in patients presenting with a STEMI.
Study design: The Groningen Intervention study for the Preservation of cardiac function with STS after STEMI (GIPS-IV) trial (NCT02899364) is a double-blind, randomized, placebo-controlled, multicenter trial, which will enroll 380 patients with a first STEMI. Patients receive STS 12.5 grams intravenously or matching placebo in addition to standard care immediately at arrival at the catheterization laboratory after providing consent. A second dose is administered 6 hours later at the coronary care unit. The primary endpoint is myocardial infarct size as quantified by cardiac magnetic resonance imaging 4 months after randomization. Secondary endpoints include the effect of STS on peak CK-MB during admission and left ventricular ejection fraction and NT-proBNP levels at 4 months follow-up. Patients will be followed-up for 2 years to assess clinical endpoints.
Conclusions: The GIPS-IV trial is the first study to determine the effect of a H2S-donor on myocardial infarct size in patients presenting with STEMI.
Keywords: Acute coronary syndrome; Cardioprotection; Hydrogen sulfide; Ischemia-reperfusion injury; Thiosulfate.
Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.
Source: PubMed