Obiettivo
Cardiogenic shock (CS) complicating acute myocardial infarction (AMI) represents a major European health care concern with mortality rates between 40-70%. Approximately 70-80% of these patients present with multivessel disease defined as coronary lesions in more than one vessel. The clinician is faced with the decision to either 1) intervene only on the culprit lesion acutely responsible for the initiation of cardiogenic shock, or 2) treat additional lesions considered hemodynamically significant but not acutely triggering the CS cascade as well. Current guidelines recommend percutaneous coronary intervention of all critical lesions. However, due to a lack of randomized trials, these recommendations are solely based on registry data and pathophysiological considerations. Aim of the randomized CULPRIT-SHOCK trial is therefore to compare a) immediate multivessel PCI versus b) culprit lesion only PCI in patients with AMI complicated by CS. A total of 706 CS patients will be randomized in several European countries. The primary endpoint will be 30-day all-cause mortality and/or severe renal failure requiring renal replacement therapy. CULPRIT-SHOCK will therefore determine the optimal percutaneous revascularization strategy in patients with AMI and multivessel disease complicated by CS. In addition, a comprehensive array of efficacy, safety and socio-economic parameters for the chosen population will be assessed. Multiple secondary endpoints and several substudies (microcirculation, biomarkers, angiography) will serve to further understand the presumed differential effects of the 2 treatment arms and to understand the underlying pathophysiology and prognostic markers. From these parameters a multivariable regression model and a risk score for the prediction of clinical prognosis and a cost-effectiveness model in AMI and CS will be developed. Furthermore, CULPRIT-SHOCK will obtain data on CS patients not meeting inclusion criteria by instituting a separate registry.
Campo scientifico
Invito a presentare proposte
FP7-HEALTH-2013-INNOVATION-1
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Meccanismo di finanziamento
CP-FP - Small or medium-scale focused research projectCoordinatore
23562 Lubeck
Germania
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Partecipanti (23)
67063 LUDWIGSHAFEN
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1105AZ Amsterdam
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1160 WIEN
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LT-08661 Vilnius
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75012 Paris
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75013 PARIS
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1000 Ljubljana
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04 628 Warszawa
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3010 BERN
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751 05 Uppsala
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G12 8QQ Glasgow
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42100 Reggio Emilia
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42100 REGGIO EMILIA
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80333 Muenchen
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04109 Leipzig
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G81 4HX GLASGOW
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04289 Leipzig
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23900 LECCO
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23900 Lecco
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2650 Edegem
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75008 Paris
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1060 WIEN
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3010 Bern
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