Clinical trial NCT02611934: Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With PCI
Official title: Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Arrest
Acute Coronary Syndrome
Lead sponsor: Collegium Medicum w Bydgoszczy
Sponsor class: OTHER
First posted: 2015-11-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mild Therapeutic Hypothermia for Patients with Acute Coronary Syndrome and Cardiac Arrest Treated with Percutaneous Coronary Intervention (UNICORN) study is designed to determine whether mild therapeutic hypothermia (MTH) applied in patients with acute coronary syndromes (ACS) and cardiac arrest treated with percutaneous coronary intervention (PCI) is associated with better clinical outcomes as compared with therapy without MTH.

Detailed description: The UNICORN study is a multi-center, international, observational, phase IV clinical trial which is aimed to investigate whether MTH applied in patients with ACS and cardiac arrest treated with PCI is associated with better clinical outcomes as compared with therapy without MTH. This trial will provide important information regarding the impact of MTH in unconscious with a score of ≤8 on the Glasgow Coma Scale on admission to the hospital after out-of-hospital cardiac arrest (OHCA) with diagnosed or presumed ACS and shockable initial rhythm.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Survivor of OHCA
* Sustained return of spontaneous circulation (ROSC) for more than 20 minutes after resuscitation
* Unconsciousness with a score of ≤8 on the Glasgow Coma Scale after ROSC
* Shockable initial rhythm
* Diagnosis or suspicion of ACS

Exclusion Criteria:

* Unwitnessed OHCA
* Obvious or suspected pregnancy
* Known serious infection/sepsis before OHCA
* Known bleeding diathesis
* Confirmed or suspected internal bleeding
* Confirmed or suspected acute stroke
* Confirmed or suspected cerebral injury
* Known serious neurological dysfunction (CPC≤4) before OHCA
* Known serious disease making 180 days of survival unlikely
* Hemodynamic instability with systolic blood pressure \<65 mmHg despite treatment
* Time delay from ROSC to MTH induction \> 240 min.
* Asystole or pulseless electrical activity (PEA) as the initial rhythm
* Initial body temperature \<30°C

Primary outcomes:
measure: All cause mortality
timeFrame: 180 days
Secondary outcomes:
measure: Neurological outcome according to Cerebral Performance Category (CPC)
timeFrame: at discharge (up to 180 days)
measure: Early stent thrombosis
timeFrame: 30 days
measure: Bleedings according to the Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 180 days
measure: Infectious complications
timeFrame: 180 days
measure: Rhythm and conductions disorders
timeFrame: 180 days
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Cardiology Department, Dr. A. Jurasz University Hospital
state: Kujawsko-pomorskie
Study officials:
affiliation: Collegium Medicum, Nicolaus Copernicus University
name: Jacek Kubica, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uminska JM, Ratajczak J, Buszko K, Sobczak P, Sroka W, Marszall MP, Adamski P, Steblovnik K, Noc M, Kubica J. Impact of mild therapeutic hypothermia on bioavailability of ticagrelor in patients with acute myocardial infarction after out-of-hospital cardiac arrest. Cardiol J. 2020;27(6):780-788. doi: 10.5603/CJ.a2019.0024. Epub 2019 Feb 25.
citation: Uminska JM, Buszko K, Ratajczak J, Lach P, Pstragowski K, Dabrowska A, Adamski P, Skonieczny G, Manitius J, Kubica J. Comparison of temperature measurements in esophagus and urinary bladder in comatose patients after cardiac arrest undergoing mild therapeutic hypothermia. Cardiol J. 2020;27(6):735-741. doi: 10.5603/CJ.a2018.0115. Epub 2018 Sep 24.