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

Acute Coronary Syndrome Clinical Trial

— UNICORN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02611934
• Other study ID #: CMUMK202C
• Status: Terminated
• Phase: N/A
• Start date: November 14, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Collegium Medicum w Bydgoszczy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiac Arrest
• Heart Arrest
• Hypothermia
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Poland	Cardiology Department, Dr. A. Jurasz University Hospital	Bydgoszcz	Kujawsko-pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Jacek Kubica

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		180 days
Secondary	Neurological outcome according to Cerebral Performance Category (CPC)		at discharge (up to 180 days)
Secondary	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
Secondary	Bleedings according to the Bleeding Academic Research Consortium (BARC) criteria	bleeding events evaluated based on the BARC definitions	180 days
Secondary	Infectious complications		180 days
Secondary	Rhythm and conductions disorders	Rhythm and conductions disorders assessed based on ECG telemetry, 12-lead ECG and ECG holter monitoring	180 days

External Links

•   Study results