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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With Percutaneous Coronary Intervention

Conditions
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Cardiac Arrest, Acute Coronary Syndrome

Intervention / Treatment
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* Procedure: Mild Therapeutic Hypothermia (MHT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild Therapeutic Hypothermia<br>OHCA survivors with diagnosed or suspected ACS | Procedure: Mild Therapeutic Hypothermia (MHT)<br>* 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.<br>|
| No Intervention: no-Mild Therapeutic Hypothermia<br>OHCA survivors with diagnosed or suspected ACS | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological outcome according to Cerebral Performance Category (CPC) |  | at discharge (up to 180 days) | 
| 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 | 30 days | 
| Bleedings according to the Bleeding Academic Research Consortium (BARC) criteria | bleeding events evaluated based on the BARC definitions | 180 days | 
| Infectious complications |  | 180 days | 
| Rhythm and conductions disorders | Rhythm and conductions disorders assessed based on ECG telemetry, 12-lead ECG and ECG holter monitoring | 180 days |