ST-segment elevated myocardial infarction, decompensatio cordis
Conditions
Interventions
Product Name: Sodium thiosulfate pentahydrate
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
INN or Proposed INN: sodium thiosulfate p
Sponsors
University Medical Centre Groningen (UMCG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years; 2. The diagnosis STEMI defined by (1) chest pain suggestive for myocardial ischemia for at least 30 minutes, the time from onset of the symptoms less than 12 hours before hospital admission, and (2) an electrocardiogram recording with ST- segment elevation of more than 0.1 mV in 2 or more contiguous leads or new left bundle branch block; 3. Symptoms and/or ST-segment deviation should be present (persisting) at time of arrival in the catheterization laboratory; 4. Primary percutaneous intervention is being considered as treatment; 5. Patient is willing to cooperate with follow-up during 2 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 380 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 380
Exclusion criteria
Exclusion criteria: 1. Prior myocardial infarction, unless maximum troponin T 220 mmHg); 13. Sedated and/or intubated patients; 14. The existence of a condition with a life expectancy of less than 1 year; 15. Contraindication for 3 Tesla (T) CMR-imaging (e.g. body weight >;150kg; known claustrophobia; 3T MRI incompatible ferromagnetic objects in the body, end-stage renal disease); 16. Pregnancy or breastfeeding women; women of childbearing potential with clinical suspicion of possible pregnancy; 17. A condition which, according to the clinical judgment of the investigator and/or treating physician, does not allow the patient to successfully participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy parameter is myocardial infarct size as measured with LGE CMR-imaging at 4 months after randomization. ;Timepoint(s) of evaluation of this end point: 4 months after randomization;Main Objective: The primary objective of the GIPS-IV is to evaluate the efficacy of sodium thiosulfate treatment compared to placebo on top of optimal reperfusion therapy for STEMI on myocardial infarct size 4 months after randomization as measured with late gadolinium enhancement cardiac magnetic resonance imaging (CMR-imaging).;Secondary Objective: Secondary CMR-imaging efficacy measures include left ventricular ejection fraction (LVEF) and myocardial perfusion reserve (MPR) at 4 month follow up. Furthermore, N-terminal fragment brain natriuretic peptide (NT-proBNP) will be assessed 4 months after randomisation. Other secondary efficacy endpoint measures will be obtained from non-mandatory CMR-imaging during hospitalization to study myocardial haemorrhage, microvascular obstruction (MVO) and myocardial salvage index (MSI). Clinical safety endpoints include all-cause mortality and combined incidence of cardiovascular events: cardiovascular death, re-infarction, re-intervention and stroke. As additional safety endpoints we will evaluate the incidence of internal cardiac defibrillator (ICD) implantation and hospitalization for heart failure or chest pain. Finally, enzymatic infarct size as assessed by peak creatine kinase, muscle-brain isoenzymes (CK)-MB) during hospitalization will be used as very early safety parameter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 4 months after randomization and after 2 years follow-up; Secondary end point(s): Efficacy: - LVEF as assessed by CMR-imaging at 4 months follow-up; - Myocardial perfusion reserve, assessed with rest and stress CMR imaging at 4 months follow-up; - NT pro-BNP at 4 months follow-up; - Other CMR-imaging parameters obtained from non-mandatory CMR-imaging during hospitalization and CMR-imaging at 4 months, including myocardial haemorrhage, MVO, MSI, LVEF, LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV) and LV mass; Safety: - Incidence of cardiovascular events within 4 months and after 2-year follow-up (all cause mortality, cardiovascular death, re-infarction, re-intervention both re-PCI and CABG [except for scheduled revascularization based on the index CAG to diagnose and treat coronary artery lesions identified during the procedures and heart team discussion, including concomitant treatment of valvular conditions, see 9.2.2 disease related adverse events], stroke, ICD implantation, hospitalization for heart failure or chest pain (defined as an overnight stay, with different dates for admission and discharge) and combined endpoints MACE defined as death, re-infarction, any revascularization not planned on index CAG) (see Table 1); - A division between cardiac and non-cardiac death is made, with a subdivision in cardiac death, namely heart failure, sudden cardiac death and other. Cardiovascular death will be confirmed by a cardiologist by examining medical records obtained from attending physicians and hospitals or general practitioners if patient died at home. Sudden cardiac death is either defined as witnessed, un-witnessed, cardiac arrest without evidence of circulatory collapse, such as hypotension, exacerbation of congestive heart failure, or altered mental status, before | — |
Countries
Netherlands
Contacts
Public ContactCardioResearch
UMCG
Outcome results
None listed