ST elevation myocardial infarction (STEMI) Circulatory System Myocardial infarction
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Registry: 1. Suspected or proven acute myocardial infarction 2. Significant ST elevation on electrocardiogram (ECG) 3. Less than 12 hours of symptom onset 4. Scheduled for primary percutaneous coronary intervention (PCI) for clinical reasons 5. Provision of verbal assent followed by written informed consent RCT: 1. Suspected or proven acute myocardial infarction 2. Significant ST elevation on ECG 3. Less than 12 hours of symptom onset 4. Scheduled for Primary PCI for clinical reasons 5. Provision of verbal assent followed by written informed consent 6. Multivessel coronary disease detected at time of angiography
Exclusion criteria
Exclusion criteria: Registry: There are no formal exclusion criteria for the CVLPRIT registry for patients that meet the inclusion criteria. RCT: 1. Any contraindication to PPCI or multi-vessel PPCI 2. Less than 18 years age 3. Clear indication for or contraindication to multivessel PPCI, according to operator judgement and the reasons will be documented 4. Severe kidney impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative major adverse cardiovascular events (MACE): all-cause mortality, recurrent MI, heart failure, need for revascularisation (PCI or CABG), measured up to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Individual components of primary composite outcome 2. Safety: Emergency coronary artery bypass graft (CABG), confirmed stroke, major bleeding, surgical repair of vascular complications, up to 12 months 3. Number of patients presenting with PPCI with significant micro vessel density (MVD) 4. Ischaemic burden at 6-8 weeks (expressed as % of total) by MPS 5. Economic assessment and cost efficacy including days in hospital at 12 months 6. Contrast induced nephropathy (rise Cr greater than 25%) or 44.2 umol/l within 48 hours persisting greater than or equal to 48 hours 7. Change in NT-ProBNP from pre-discharge to 12 months 8. Echocardiographic left ventricular ejection fraction (LVEF) and wall motion score (discharge and 12 months) 9. Quality of Life Score at 12 Months (EuroQol questionnaire) 10. Infarct size, extent of microvascular obstruction, myocardium salvaged, left Ventricular (LV) volumes and ejection fraction (EF) at discharge by CMR and new myocardial injury and volumes at 9 - 12 months | — |
Countries
United Kingdom