Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With PCI (UNICORN)

Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With Percutaneous Coronary Intervention

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.

Study Overview

• Status: Terminated
• Conditions: Acute Coronary Syndrome; Cardiac Arrest
• Intervention / Treatment: Procedure: Mild Therapeutic Hypothermia (MHT)

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-094
      • Cardiology Department, Dr. A. Jurasz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild Therapeutic Hypothermia; OHCA survivors with diagnosed or suspected ACS	Procedure: Mild Therapeutic Hypothermia (MHT); The induction with ice packs and infusion of 0.9% sodium chloride (NaCl) at the temperature of 4˚C. MHT will be maintained with a MTH-dedicated catheter introduced into the inferior vena cava through the femoral vein during PCI. MTH will be maintained for at least 12 hours at target temperature of 33˚C. The rewarming phase will be conducted in an actively controlled manner (0.3˚C per hour). The patient's core temperature will be independently measured in the urinary bladder as well as in the lower one third of the oesophagus using a dedicated catheter and tube. All patients treated with MTH will be mechanically ventilated with a concomitant continuous intravenous infusion of propofol and fentanyl for sedation and analgesia.
No Intervention: no-Mild Therapeutic Hypothermia; OHCA survivors with diagnosed or suspected ACS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All cause mortality	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological outcome according to Cerebral Performance Category (CPC)		at discharge (up to 180 days)
Early stent thrombosis	Definite or confirmed stent thrombosis - symptoms suggestive of an acute coronary syndrome and angiographic or pathologic confirmation of stent thrombosis within 30 days post stent implantation	30 days
Bleedings according to the Bleeding Academic Research Consortium (BARC) criteria	bleeding events evaluated based on the BARC definitions	180 days
Infectious complications		180 days
Rhythm and conductions disorders	Rhythm and conductions disorders assessed based on ECG telemetry, 12-lead ECG and ECG holter monitoring	180 days

Collaborators and Investigators

• Sponsor: Jacek Kubica
• Investigators: Principal Investigator: Jacek Kubica, MD, PhD, Collegium Medicum, Nicolaus Copernicus University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Study results

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 23, 2015

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Body Temperature Changes; Syndrome; Heart Arrest; Acute Coronary Syndrome; Hypothermia
• Other Study ID Numbers: CMUMK202C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No