heart attack myocardial infarction
Conditions
Interventions
Additional procedures for the study in the intervention group
1) A normal pressure wire temperature will be positioned in the distal coronary
artery
2) Hypothermia is started during 10 min (inductio
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients will be eligible for this study if they are admitted for acute anterior wall ST-elevation myocardial infarction with a total ST-segment deviation of at least 5 mm and presenting within 6 hours after onset of complaints. Patients should have a TIMI 0 or 1 flow in the infarction related artery. Patients should be hemodynamically stable and in an acceptable clinical condition.
Exclusion criteria
Exclusion criteria: * Age 80 year * Cardiogenic shock or hemodynamically unstable patients * Patients with previous myocardial infarction in the culprit artery of with previous bypass surgery * Very tortuous or calcified coronary arteries * Complex or long-lasting primary PCI expected * Severe concomitant disease or conditions with a life expectancy of less than one year * Inability to understand and give informed consent * Known contra-indication for MRI * Pregnancy * Severe conduction disturbances necessitating implantation of temporary Pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRIMARY ENDPOINT Infarct size (as a percentage of total left ventricular mass) on MRI at 3 months after the index event. | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite of all-cause mortality and hospitalization for heart failure at 3 months Composite of all-cause mortality and hospitalization for heart failure at 1 year All-cause mortality at 3 months All-cause mortality at 1 year Hospitalization for heart failure at 3 months Hospitalization for heart failure at 1 year Cardiac death at 3 months Cardiac death at 1 year Implantation of internal cardiodefibrillators for primary prevention at 1 year. Implantation of internal cardiodefibrillators for secondary prevention at 1 year. MRI efficacy parameters as specified below Peak value of high-sensitivity troponin T (hs-TnT) Peak value of creatine kinase (CK) Peak value of creatine kinase-MB mass (CK-MB) N-terminal pro-brain natriuretic peptide (NT-proBNP) at 3 months N-terminal pro-brain natriuretic peptide (NT-proBNP) at 1 year Left ventricular ejection fraction measured by echocardiography (biplane Simpson*s method) at 3 months Left ventricular ejection fraction measured by echocardiography (biplane Simpson*s method) at 1 year Wall motion score index (WMSI) by echocardiography at 3 months Wall motion score index (WMSI) by echocardiography at 1 year Secondary MRI efficacy endpoints at baseline (5-7 days after the index event) First pass microvascular obstruction extent (FP MVO); NB first pass will be acquired in 3 SAX levels to provide an index of %LV FP MVO Early MVO extent (% of LV) on 1 min post-gadolinium contrast enhanced MRI, adjusted for area at-risk Late MVO (presence / absence) on LGE Initial infarct size (LGE) Initial MSI (area-at-risk minus initial infarct size/area-at-risk) Left ventricular end-diastolic volume index (LVEDVI) Left ventricular end-systolic volume index (LVESVI) Left ventricular global longitudinal strain Left ventricular circumferential strain (mid-LV) Left ventricular ejection fraction (LVEF) Systolic wall thickening in the culprit artery territory Wall motion score index (WMSI) Myocardial haemorrhage (prese | — |
Countries
Netherlands
Outcome results
None listed