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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02611934
Recruitment Status : Terminated (Due to insufficient enrollment)
First Posted : November 23, 2015
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Jacek Kubica, Collegium Medicum w Bydgoszczy

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Acute Coronary Syndrome Procedure: Mild Therapeutic Hypothermia (MHT) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With Percutaneous Coronary Intervention
Actual Study Start Date : November 14, 2017
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 180 days ]

Secondary Outcome Measures :
  1. Neurological outcome according to Cerebral Performance Category (CPC) [ Time Frame: at discharge (up to 180 days) ]
  2. Early stent thrombosis [ Time Frame: 30 days ]
    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

  3. Bleedings according to the Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 180 days ]
    bleeding events evaluated based on the BARC definitions

  4. Infectious complications [ Time Frame: 180 days ]
  5. Rhythm and conductions disorders [ Time Frame: 180 days ]
    Rhythm and conductions disorders assessed based on ECG telemetry, 12-lead ECG and ECG holter monitoring


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611934


Locations
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Poland
Cardiology Department, Dr. A. Jurasz University Hospital
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-094
Sponsors and Collaborators
Jacek Kubica
Investigators
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Principal Investigator: Jacek Kubica, MD, PhD Collegium Medicum, Nicolaus Copernicus University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jacek Kubica, Head of Cardiology, Principal investigator, Collegium Medicum w Bydgoszczy
ClinicalTrials.gov Identifier: NCT02611934    
Other Study ID Numbers: CMUMK202C
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Heart Arrest
Syndrome
Hypothermia
Disease
Pathologic Processes
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Body Temperature Changes