NCT02611934

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2015

Completed
2 years until next milestone

Study Start

First participant enrolled

November 14, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

3.1 years

First QC Date

November 18, 2015

Last Update Submit

January 29, 2021

Conditions

Cardiac ArrestAcute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    180 days

Secondary Outcomes (5)

  • Neurological outcome according to Cerebral Performance Category (CPC)

    at discharge (up to 180 days)

  • Early stent thrombosis

    30 days

  • Bleedings according to the Bleeding Academic Research Consortium (BARC) criteria

    180 days

  • Infectious complications

    180 days

  • Rhythm and conductions disorders

    180 days

Study Arms (2)

Mild Therapeutic Hypothermia

EXPERIMENTAL

OHCA survivors with diagnosed or suspected ACS

Procedure: Mild Therapeutic Hypothermia (MHT)

no-Mild Therapeutic Hypothermia

NO INTERVENTION

OHCA survivors with diagnosed or suspected ACS

Interventions

Mild Therapeutic Hypothermia (MHT)PROCEDURE

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.

Mild Therapeutic Hypothermia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Department, Dr. A. Jurasz University Hospital

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland

Location

Related Publications (2)

  • 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.

    PMID: 30799546DERIVED

  • 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.

    PMID: 30246234DERIVED

Related Links

MeSH Terms

Conditions

Heart ArrestAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular Diseases

Study Officials

  • Jacek Kubica, MD, PhD

    Collegium Medicum, Nicolaus Copernicus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Cardiology, Principal investigator

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 23, 2015

Study Start

November 14, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 2, 2021

Record last verified: 2021-01

Locations

PL(1)