myoacardial infarction
Conditions
Interventions
Patients are randomised in an 1:1 ratio to be treated with STS 12.5g
intravenously (i.v.) or matched placebo immediately after arrival at the
catheterization laboratory (cath-lab) and a repeated dos
cardiac magnetic resonance imaging
Infarct size
Sodium thiosulfate
STEMI
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
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 presence of 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.
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 endpoint is infarct size as measured with cardiac magnetic resonance imaging (CMR-imaging) 4 months after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
The Netherlands
Outcome results
None listed