NCT02611934

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Jacek Kubica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Arrest
• Acute Coronary Syndrome

Interventions

Type	Name	Description
PROCEDURE	Mild Therapeutic Hypothermia (MHT)	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.

Timeline

• Start date: 2017-11-14
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2015-11-23
• Last updated: 2021-02-02

Locations

1 site across 1 country: Poland