COOL-AMI EU PIVOTAL TRIAL
Research type
Research Study
Full title
COOL-AMI EU PIVOTAL TRIAL: A multicenter, prospective, randomized-controlled trial to assess the safety and effectiveness of cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction.
IRAS ID
230205
Contact name
Thomas Keeble
Contact email
Sponsor organisation
Zoll Circulation Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 30 days
Research summary
COOL-AMI EU Pivotal trial is a multicentre randomised control study, aiming to recruit almost 500 participants.
Its objective is to evaluate the safety and effectiveness of cooling the human body (therapeutic hypothermia) using the ZOLL ProteusTM Intravascular Temperature Management (ITVM) System as an additional therapy for patient presenting with a large heart attack (acute anterior myocardial infarction) and undergoing an urgent stent procedure (percutaneous coronary intevention / PCI) in comparison with patients with large heart attack and undergoing stent treatment only. It follows a Pilot study (COOL AMI EU Pilot), which showed safety of the device and the protocol in 50 patients and a statistically non-significant trend towards smaller heart attack size.
Evaluation of heart attack size will be performed by cardiac magnetic resonance imaging at 4-6 days following the procedure. Participant demographics and various baseline characteristics will also be collected. Additional clinical data collected and evaluated will include the number of patients who can successfully be enrolled and randomised, the timing of subject presentation to hospital, the timing of cooling and adjunctive interventions, the timing of reaching the target temperature zone, temperature at stent procedure, subsequent maintenance of hypothermia and temperature data from the IVTM System. Observations will be evaluated relating to the use of the ZOLL Proteus IVTM System and how it performs in relation to the induction of therapeutic cooling and follow-up cMR imaging. New York Health Association (NYHA) Functional Class will be evaluated through 12 month follow-up, and Kansas City Cardiomyopathy Questionnaire (KCCQ) will be administered on those study subjects who experienced heart failure through 12 month follow-up to evaluate their quality of life.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
17/EE/0394
Date of REC Opinion
9 Jan 2018
REC opinion
Further Information Favourable Opinion