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

J

Jacek Kubica

Status

Terminated

Conditions

Acute Coronary Syndrome
Cardiac Arrest

Treatments

Procedure: Mild Therapeutic Hypothermia (MHT)

Study type

Interventional

Funder types

Other

Identifiers

NCT02611934
CMUMK202C

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 2 patient groups

Mild Therapeutic Hypothermia
Experimental group
Description:
OHCA survivors with diagnosed or suspected ACS
Treatment:
Procedure: Mild Therapeutic Hypothermia (MHT)
no-Mild Therapeutic Hypothermia
No Intervention group
Description:
OHCA survivors with diagnosed or suspected ACS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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