Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction

Study Overview
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Brief Summary
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Although recommended therapy for patients with ST-segment elevation myocardial infarction is primary PCI, it remains unestablished whether patients with a symptom duration of more 12 hours benefit from acute revascularisation. This study aims to investigate whether acute intervention is superior to subacute intervention in these patients.

Detailed Description
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The recommended therapy for patients with ST-segment elevation myocardial infarction (STEMI) is to restore normal coronary blood flow with timely reperfusion by percutaneous coronary intervention (PCI), and thereby minimize the extent of cell death and preserving cardiac function. The duration of ischemia and timely PCI are major determinants for the size of the myocardial infarction and prognosis. Thus, acute PCI should be performed within 12 hours after symptom onset. The effect of PCI and timing of PCI are, however, much more uncertain for late presenters who contact the health service > 12 hours from symptom. Thus, it is still unknown whether late presenters should be treated with acute PCI or medical treatment with delayed PCI (24-72 h after first medical contact). The study investigates the effect on final salvage index evaluated by magnetic resonance imaging of acute PCI of late presenters. The overall objective of the study is to investigate whether late presenters may benefit from acute PCI, and thus whether to extend the currently recommended time limit of 12 hours for acute PCI in patients with STEMI.

Official Title
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Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction

Conditions
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ST-segment Elevation Myocardial Infarction, Ischemic Heart Disease

Intervention / Treatment
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* Procedure: PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria: Patients more than 18 years of age. STEMI > 12 hours and < 36 hours. Clinical stable, i.e. no on going angina, hemodynamically stable (systolic BP > 90) and Killip class < 3. Exclusion Criteria: Clinical instability which requires an acute invasive strategy. Left main occlusion or multivessel disease which requires CABG. Previous Q-wave infarction in the current infarct related artery. Left Bundle Branch Block (LBBB). Severe renal insufficiency. Pacemaker Chronic atrial fibrillation. Previous Coronary Artery Bypass Surgery (CABG). Pregnancy. Other severe illness with life expectancy less than 1 year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute PCI<br>Acute re-opening of the occluded coronary artery including premedication as for primary PCI within 12 hours | Procedure: PCI<br>* Guideline directed Percutaneous Coronary Intervention<br>|
| Active Comparator: Subacute PCI<br>Standard subacute re-opening of the occluded coronary artery including premedication as for subacute PCI within 72 hours | Procedure: PCI<br>* Guideline directed Percutaneous Coronary Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute salvage index evaluated by MRI | MRI within 48 timer after index admission will be used to measure are at risk (AAR, T2-weighted) and acute infarct size (IZ). Acute salvage index is (AAR-IZ)/AAR | 1-2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final infarct size | Please see above | 3 months | 
| Final myocardial salvage index | As for primary endpoint but IZ is measured within the index admission | 1-2 days | 
| Acute infarct size |  | 1-2 days | 
| Microvascular obstruction (MVO) |  | 1-2 days | 
| Left Ventricular Ejection Fraction (LVEF) | Measured by MRI | 1-2 days and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Late presenters, Primary percutaneous coronary intervention, Reperfusion, Angioplasty, Duration of ischemia, Cardiovascular magnetic resonance imaging