A multicentre, prospective, randomised controlled trial to assess the safety and effectiveness of cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction: the COOL AMI EU Pivotal Trial: COOL AMI EU Pivotal Trial

Autor: Adam Witkowski, Jan Z. Peruga, Misa Fister, Andrejs Erglis, Béla Merkely, Daniel Aradi, Imre Ungi, Milovan Petrovic, Thomas R. Keeble, Peter Blasko, Vladan Vukcevic, Bojan Stanetic, Marko Noc, John Davies, Bernhard Metzler, Gergely Nagy, Michael Holzer, Aleksandar N. Neskovic, Róbert Gábor Kiss, David Erlinge, Joško Bulum, Beata Średniawa, Iván Horváth, István Édes, Peep Laanmets, Martin Hudec
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: EuroIntervention
Popis: BACKGROUND: Despite primary PCI (PPCI), ST-elevation myocardial infarction (STEMI) can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signals for reduction in IS in anterior STEMI. AIMS: We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to PPCI in conscious patients, with anterior STEMI, without cardiac arrest. METHODS: Hypothermia was induced using the ZOLL™ Proteus™️ intravascular cooling system. After randomisation of 111 patients, 58 to hypothermia and 53 to control groups, the study was prematurely discontinued by the sponsor due to inconsistent patient logistics between the groups resulting in significantly longer total ischaemic delay in the hypothermia group (232 vs 188 minutes; p
Databáze: OpenAIRE