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
de Koning, Marie-Sophie L Y; van Dorp, Paulien; Assa, Solmaz; Hartman, Minke H T; Voskuil, Michiel; Anthonio, Rutger L; Veen, Duco; Prado, Gabija Pundziute-Do; Leiner, Tim; van Goor, Harry; van der Meer, Peter; van Veldhuisen, Dirk J; Nijveldt, Robin; Lipsic, Erik; van der Harst, Pim
(2022) American Heart Journal, volume 243, pp. 167 - 176
(Article)
Abstract
BACKGROUND: Ischemia and subsequent reperfusion cause myocardial injury in patients presenting with ST-segment elevation myocardial infarction (STEMI). Hydrogen sulfide (H 2S) 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 H 2S-donor sodium thiosulfate
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(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 H 2S-donor on myocardial infarct size in patients presenting with STEMI.
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Keywords: Acute coronary syndrome, Cardioprotection, Hydrogen sulfide, Ischemia-reper fusion injury, Thiosulfate, Ischemia-reperfusion injury, Cardiology and Cardiovascular Medicine, Journal Article
ISSN: 0002-8703
Publisher: Mosby Inc.
Note: Funding Information: The development of the protocol and progress of the study will be under supervision of the trial steering committee (Supplementary Material I). The GIPS-IV trial data will be captured in a dedicated electronic database (eCRF) (Research Electronic Data Capture; REDCap). The eCRF will be independently monitored for completeness and accuracy according to a pre-specified monitoring plan by Schutjens Clinical Research Consultancy (Supplementary Material I). Trial data will be reviewed periodically by an independent DSMB. The DSMB consist of 4 independent members with expertise in trial methodology, (interventional) cardiology and biostatistics (Supplementary Material I). The DSMB reviews accumulating data in a semi-blinded fashion (group A vs group B) to detect possible safety concerns that could result in their recommendation to modify the protocol or prematurely terminate the execution of the trial. Clinical endpoints will be adjudicated by a blinded Endpoint Adjudication Committee, consisting of 3 members with expertise in (interventional) cardiology (Supplementary Material I). For valorization purposes a users’ committee will be installed (Supplementary Material I). Database lock and subsequent deblinding for primary analyses will be performed when all participants have completed 4 months follow-up, infarct sizes have been determined by the core lab and clinical events up to 4 months have been adjudicated. This study is supported by the Netherlands Organization for Health Research and Development, Siemens healthcare GmbH and the University Medical Center Groningen. The subsidizers had no role in the design and conduct of the study, all study analyses, and drafting or editing of the paper, and its final contents. Funding Information: This study is supported by a grant of the Netherlands Organization for Health Research and Development (ZonMW; project No: 95105012 ), Siemens healthcare GmbH (Push project IPA No. 10 ) and the University Medical Center Groningen. Publisher Copyright: © 2021 The Author(s)
(Peer reviewed)
