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 - 26/11/21
, Paulien van Dorp, MD a, Solmaz Assa, MD, PhD a, Minke HT Hartman, MD, PhD a, Michiel Voskuil, MD, PhD b, Rutger L Anthonio, MD, PhD c, Duco Veen, PhD d, Gabija Pundziute-Do Prado, MD, PhD a, Tim Leiner, MD, PhD e, Harry van Goor, PhD f, Peter van der Meer, MD, PhD a, Dirk J van Veldhuisen, MD, PhD a, Robin Nijveldt, MD, PhD g, Erik Lipsic, MD , PhD a, Pim van der Harst, MD, PhD a, bRésumé |
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.
Le texte complet de cet article est disponible en PDF.Keywords : Acute coronary syndrome, Hydrogen sulfide, Thiosulfate, Ischemia-reperfusion injury, Cardioprotection
Plan
Vol 243
P. 167-176 - janvier 2022 Retour au numéro
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