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

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

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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