COOL-AMI EU PILOT TRIAL

• Research type

  Research Study

• Full title

  A MULTICENTER, PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL TO ASSESS COOLING AS AN ADJUNCTIVE THERAPY TO PERCUTANEOUS INTERVENTION IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION

• IRAS ID

  181404

• Contact name

  John Davies

• Sponsor organisation

  Zoll Circulation Inc

• Clinicaltrials.gov Identifier

  NCT02509832

• Duration of Study in the UK

  1 years, 6 months, 31 days

• Research summary

  This trial aims to evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL® ProteusTM Intravascular Temperature Management (IVTM) System into the treatment protocols for subjects who present with acute anterior myocardial infarction (AMI) prior to performing percutaneous coronary intervention (PCI). The trial will assess the proportions of subjects who complete the follow-up and cMR imaging requirements during the 30 day follow-up period and will assess anterior infarction size using cMR imaging at 4-6 days following the index procedure. In addition, the trial will evaluate the incidence of serious adverse events through the 30-day follow-up period and will evaluate the proportions of subjects experiencing death and hospitalization due to heart failure throughout the 12 month follow-up.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  15/EE/0423

• Date of REC Opinion

  23 Mar 2016

• REC opinion

  Further Information Favourable Opinion