FIT (Fast Infarction Treatment): Complete Revascularization During Primary Percutaneous Coronary Intervention (PCI) Can be Achieved Safely With an Improved Clinical Outcome During the Indexed Hospitalization.

Study Overview
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Brief Summary
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Few reports described outcomes of complete compared with infarct related artery (IRA) only revascularization in patients with ST elevation myocardial infarction (STEMI) and multivessel coronary disease (CAD). The purpose of this study is to determine outcome (death, myocardial infarction, target vessel failure) of 180 consecutive patients with STEMI and multivessel CAD undergoing primary angioplasty. Before the first angioplasty patients are randomized to 2 different strategies: 1) culprit vessel angioplasty only, 2) staged revascularization.

Official Title
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Phase III Study, Multivessel Percutaneous Treatment During Myocardial Infarction

Conditions
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Myocardial Infarction, Ischemia, Heart Failure, Necrosis, Stents

Intervention / Treatment
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* Procedure: Coronary angioplasty all lesions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: myocardial acute infarction prolonged chest pain (>20 minute) started less <12 hours before arrive in hospital ST segment elevation of >1mm in >2 contiguous leads new left bundle branch block diameter of the coronary suitable of angioplasty >2mm the patients agrees to the study protocol and provides a written consensus two or more coronary suitable for angioplasty Exclusion Criteria: refused written consensus hypersensitivity or contraindication to any of the following medications: heparin bivalirudin aspirin prasugrel stainless steel history of bleeding cardiogenic shock (PA < 90mmHg) chronic total occlusion in the second lesion TIMI Flow < II in the culprit lesion recent pregnancy history of intra-cerebral major hemorrhagic stroke an elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first six months post enrollment life expectancy <1 year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multivessel revascularization<br>Complete Revascularization : the Infarcted related artery was opened followed by dilatation of other significantly narrowed arteries during the same procedure | Procedure: Coronary angioplasty all lesions<br>* treatment by coronary angioplasty and drug eluting stent of all lesions, adjunctive use of prasugrel and bivalirudin<br>* Other names: drug eluting stent, prasugrel, bivalirudin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death at 30 days |  | 1 month | 
| stent thrombosis |  | 1 year | 
| target vessel failure |  | 1 year | 
| re-acute myocardial infarction |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding |  | 1 month | 
| timi frame count |  | 1 day | 
| vascular site access complications |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular diseases, heart disease, hemorrhage, coronary angioplasty, drug eluting stents