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

Primary Purpose

Cardiac Arrest, Acute Coronary Syndrome

Status
Terminated
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Mild Therapeutic Hypothermia (MHT)
Sponsored by
Jacek Kubica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiology Department, Dr. A. Jurasz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mild Therapeutic Hypothermia

no-Mild Therapeutic Hypothermia

Arm Description

OHCA survivors with diagnosed or suspected ACS

OHCA survivors with diagnosed or suspected ACS

Outcomes

Primary Outcome Measures

All cause mortality

Secondary Outcome Measures

Neurological outcome according to Cerebral Performance Category (CPC)
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
Bleedings according to the Bleeding Academic Research Consortium (BARC) criteria
bleeding events evaluated based on the BARC definitions
Infectious complications
Rhythm and conductions disorders
Rhythm and conductions disorders assessed based on ECG telemetry, 12-lead ECG and ECG holter monitoring

Full Information

First Posted
November 18, 2015
Last Updated
January 29, 2021
Sponsor
Jacek Kubica
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1. Study Identification

Unique Protocol Identification Number
NCT02611934
Brief Title
Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With PCI
Acronym
UNICORN
Official Title
Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to insufficient enrollment
Study Start Date
November 14, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jacek Kubica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mild Therapeutic Hypothermia
Arm Type
Experimental
Arm Description
OHCA survivors with diagnosed or suspected ACS
Arm Title
no-Mild Therapeutic Hypothermia
Arm Type
No Intervention
Arm Description
OHCA survivors with diagnosed or suspected ACS
Intervention Type
Procedure
Intervention Name(s)
Mild Therapeutic Hypothermia (MHT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
All cause mortality
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Neurological outcome according to Cerebral Performance Category (CPC)
Time Frame
at discharge (up to 180 days)
Title
Early stent thrombosis
Description
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
Time Frame
30 days
Title
Bleedings according to the Bleeding Academic Research Consortium (BARC) criteria
Description
bleeding events evaluated based on the BARC definitions
Time Frame
180 days
Title
Infectious complications
Time Frame
180 days
Title
Rhythm and conductions disorders
Description
Rhythm and conductions disorders assessed based on ECG telemetry, 12-lead ECG and ECG holter monitoring
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacek Kubica, MD, PhD
Organizational Affiliation
Collegium Medicum, Nicolaus Copernicus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Department, Dr. A. Jurasz University Hospital
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-094
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
30799546
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.
Results Reference
derived
PubMed Identifier
30246234
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.
Results Reference
derived
Links:
URL
https://journals.viamedica.pl/cardiology_journal/article/view/CJ.a2019.0023/47613
Description
Study results

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

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