title: Metformin in non-diabetic patients presenting with ST elevation myocardial infarction: rationale and design of the glycometabolic intervention as adjunct to primary percutaneous intervention in ST elevation myocardial infarction (GIPS)-III trial.
abstract: BACKGROUND
  Left ventricular dysfunction and the development of heart failure is a frequent and serious complication of myocardial infarction. Recent animal experimental studies suggested that metformin treatment reduces myocardial injury and preserves cardiac function in non-diabetic rats after experimental myocardial infarction. We will study the efficacy of metformin with the aim to preserve left ventricular ejection fraction in non-diabetic patients presenting with ST elevation myocardial infarction (STEMI).
  
  
  METHODS
  The Glycometabolic Intervention as adjunct to Primary percutaneous intervention in ST elevation myocardial infarction (GIPS)-III trial is a prospective, single center, double blind, randomized, placebo-controlled trial. Three-hundred-and-fifty patients, without diabetes, requiring primary percutaneous coronary intervention (PCI) for STEMI will be randomized to metformin 500 mg twice daily or placebo treatment and will undergo magnetic resonance imaging (MRI) after 4 months. Major exclusion criteria were prior myocardial infarction and severe renal dysfunction. The primary efficacy parameter is left ventricular ejection fraction 4 months after randomization. Secondary and tertiary efficacy parameters include major adverse cardiac events, new onset diabetes and glycometabolic parameters, and echocardiographic diastolic function. Safety parameters include renal function deterioration and lactic acidosis.
  
  
  CONCLUSIONS
  The GIPS-III trial will evaluate the efficacy of metformin treatment to preserve left ventricular ejection fraction in STEMI patients without diabetes.
authors.affiliation: Department of Cardiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, PO Box 30.001, Groningen, the Netherlands. c.p.h.lexis@umcg.nl
authors.forename: Chris P H
authors.initials: CP
authors.lastname: Lexis
authors.forename: Iwan C C
authors.initials: IC
authors.lastname: van der Horst
authors.forename: Erik
authors.initials: E
authors.lastname: Lipsic
authors.forename: Pim
authors.initials: P
authors.lastname: van der Harst
authors.forename: Anouk N A
authors.initials: AN
authors.lastname: van der Horst-Schrivers
authors.forename: Bruce H R
authors.initials: BH
authors.lastname: Wolffenbuttel
authors.forename: Rudolf A
authors.initials: RA
authors.lastname: de Boer
authors.forename: Albert C
authors.initials: AC
authors.lastname: van Rossum
authors.forename: Dirk J
authors.initials: DJ
authors.lastname: van Veldhuisen
authors.forename: Bart J G L
authors.initials: BJ
authors.lastname: de Smet
mesh_terms: D005951:Glucose Tolerance Test; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008687:Metformin / Q000627:therapeutic use*; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000601:surgery; D062645:Percutaneous Coronary Intervention; D018487:Ventricular Dysfunction, Left / Q000188:drug therapy* / Q000601:surgery; D016277:Ventricular Function, Left / Q000187:drug effects / Q000502:physiology
chemical_list: D007004:Hypoglycemic Agents; D008687:Metformin