Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical, echocardiographic and angiographic outcome of distal protection in the infarct related coronary artery and implantation of drug eluting versus bare metal stents in patients with ST-elevation myocardial infarctions treated acutely with percutaneous coronary intervention.

Official Title
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Drug Elution and DIstal Protection During Percutaneous CoronAry Intervention in sT Elevation Myocardial InfarctiON. Acronym: Dedication

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Distal protection and drug eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute onset typical chest pain of < 12 hours' duration ST-elevation of > 4 mm (1mm = 0.1 mV) in contiguous leads of the electrocardiogram High grade stenosis or occlusion of a native major coronary artery that can be crossed with a soft or intermediate tip guidewire Possibility to perform distal protection of the infarct-related artery Exclusion Criteria: History of previous myocardial infarction Use of fibrinolytic agents for the index infarction Left main stenosis Heavily calcification of abdominal aorta or occlusive iliofemoral disease hampering access to the coronary ostias by the femoral route Known renal failure Other significant cardiac disease Other severe disease with an expected survival < 1 year Known allergy against clopidogrel or contrast media that can not be avoided/limited by medication Linguistic difficulties needing an interpreter Gastrointestinal bleeding within 1 month Childbearing potential or pregnancy Participation in another study

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Distal protection and drug eluting stent|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ST segment resolution |  | 90 min | 
| Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up). |  | immediately after and at 8 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis |  | 8 months | 
| maximal elevations in blood concentrations of CK-MB enzyme and troponin-T |  | Post procedure | 
| wall motion index |  | During hospitalisation: day 3-5 | 
| Minimal lumen diameter |  | 8 months | 
| frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment. |  | 8 months | 
| Occurrence of stent thrombosis and MACE. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary PCI, distal protection, drug eluting stent, restenosis