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

Not Applicable

Terminated

• Conditions: Cardiac Arrest; Acute Coronary Syndrome
• Interventions: Procedure: Mild Therapeutic Hypothermia (MHT)

• Registration Number: NCT02611934
• Lead Sponsor: Jacek Kubica

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.

Study Timeline

• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-23
• Study Start: 2017-11-14
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild Therapeutic Hypothermia	Mild Therapeutic Hypothermia (MHT)	OHCA survivors with diagnosed or suspected ACS

Primary Outcome Measures

Name	Time	Method
All cause mortality	180 days

Secondary Outcome Measures

Name	Time	Method
Neurological outcome according to Cerebral Performance Category (CPC)	at discharge (up to 180 days)
Early stent thrombosis	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
Infectious complications	180 days
Rhythm and conductions disorders	180 days	Rhythm and conductions disorders assessed based on ECG telemetry, 12-lead ECG and ECG holter monitoring
Bleedings according to the Bleeding Academic Research Consortium (BARC) criteria	180 days	bleeding events evaluated based on the BARC definitions

Trial Locations

Locations (1)

Cardiology Department, Dr. A. Jurasz University Hospital; 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland