Mild therapeutic hypothermia for patients with acute coronary syndrome and cardiac arrest treated with percutaneous coronary intervention (UNICORN). The design and rationale for the prospective, observational, multicenter study

Abstract

Mild therapeutic hypothermia for patients with acute coronary syndrome and cardiac arrest treated with percutaneous coronary intervention (UNICORN). The design and rationale for the prospective, observational, multicenter study Methods. The UNICORN study is a phase IV, prospective, international, multi-centre, observational study designed to assess the effectiveness of MTH in patients after OHCA with shockable rhythm presenting with acute coronary syndrome (ACS). The trial is expected to include up to 500 patients. Depending on the availability of MTH in each study centre, besides the routine treatment of ACS in OHCA survivors, patients will either undergo MTH according to a uniform protocol or will not undergo MTH (250 patients per group). The primary end-point of the study is all cause mortality at 180 days after enrolment. Secondary end-points include: neurological outcome at discharge, stent thrombosis at 30 days, bleeding according to the BARC criteria, infectious complications at 180 days, and rhythm and conduction disorders at 180 days.Ethics and dissemination. The study received approval from the Local Ethics Committee to conduct the study (Komisja Bioetyczna Uniwersytetu Mikołaja Kopernika w Toruniu przy Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy; study approval reference number KB 615/2015). The study results will be disseminated through conference presentations and publications in peer-reviewed journals.Trial registration. ClinicalTrials.gov identifier: NCT02611934 (18 November 2015).

Comparison of temperature measurements in esophagus and urinary bladder in comatose patients after cardiac arrest undergoing mild therapeutic hypothermia

“…This temperature comparison protocol was a part of a prospective, observational, multicenter cohort study entitled Mild Therapeutic Hypothermia for Patients with Acute Coronary Syndrome and Cardiac Arrest Treated with Percutaneous Coronary Intervention (the UNICORN trial) [14]. The study was conducted in accordance with the principles contained in the Declaration of Helsinki and Good Clinical Practice guidelines.…”

“…After admission to the study center and confirmation of initial diagnosis, patients were screened for eligibility to the trial. All enrolled subjects were treated with MTH in addition to standard therapy baccording to the previously described protocol [14]. Inclusion criteria were defined as: -age ≥ 18 years; -OHCA survivor; -sustained return of spontaneous circulation (ROSC) for more than 20 min after resuscitation; -unconsciousness with a score of ≤ 8 on the Glasgow Coma Scale after ROSC; -shockable initial rhythm; -diagnosis or suspicion of ACS.…”

“…The exclusion criteria included: -unwitnessed OHCA; -obvious or suspected pregnancy; -known serious infection before OHCA; -known bleeding diathesis; -confirmed or suspected internal bleeding; -confirmed or suspected acute stroke; -confirmed or suspected cerebral injury; -known serious neurological dysfunction before OHCA (Cerebral Performance Category ≤ 4); -known serious disease making 180 days of survival unlikely; -hemodynamic instability with systolic blood pressure < 65 mmHg despite the treatment; -time delay from ROSC to MTH induction > 240 min; -asystole or pulseless electrical activity as the initial rhythm [14].…”

Platelet reactivity during mild therapeutic hypothermia in patients with acute myocardial infarction treated with ticagrelor: study protocol of a single-centre study

“…Several studies, including our own [4,5] as well as studies published by Casella et al [6] and Dumas et al [7], suggest that the combination of PCI and MTH is more effective than any of these methods used alone in the treatment of OHCA patients with ACS. However, there is a serious limitation of MTH in patients with acute myocardial infarction treated with PCI as described by Penela et al [8].…”

“…The induction of hypothermia will start upon hospital admission, directly after the initial assessment of consciousness [5], and will employ the following: -ice packs -placed on the largest possible surface area of the patient's body: neck, armpits, abdomen, groin, lower limbs; -infusion of cold fluid -1-1.5 L of 4°C lactated Ringer's solution or cold normal saline infused into the peripheral veins; -washing the patient's skin with alcohol after completion of the diagnostic and invasive procedures, and after final qualification for MTH.…”