Marie-Sophie Ly de Koning1, Paulien van Dorp2, Solmaz Assa2, Minke Ht Hartman2, Michiel Voskuil3, Rutger L Anthonio4, Duco Veen5, Gabija Pundziute-Do Prado2, Tim Leiner6, Harry van Goor7, Peter van der Meer2, Dirk J van Veldhuisen2, Robin Nijveldt8, Erik Lipsic2, Pim van der Harst9. 1. Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands. Electronic address: m.s.l.y.de.koning@umcg.nl. 2. Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands. 3. Department of Cardiology, Division of Heart & Lungs, University Medical Center Utrecht, Utrecht, the Netherlands. 4. Department of Cardiology, Treant hospital location Scheper, Emmen, the Netherlands. 5. Department of Methodology and Statistics, University Medical Center Utrecht, Utrecht, the Netherlands. 6. Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands. 7. Department of Pathology and Medical Biology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands. 8. Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands. 9. Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Department of Cardiology, Division of Heart & Lungs, University Medical Center Utrecht, Utrecht, the Netherlands.
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.
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.