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

• Sponsor: Jacek Kubica (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02611934
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Actual Duration (Months): 37.6
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest; Acute Coronary Syndrome	Procedure: Mild Therapeutic Hypothermia (MHT)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With Percutaneous Coronary Intervention
• Actual Study Start Date: Nov 14, 2017
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mild Therapeutic Hypothermia OHCA survivors with diagnosed or suspected ACS	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.
No Intervention: no-Mild Therapeutic Hypothermia OHCA survivors with diagnosed or suspected ACS

Outcome Measures

Primary Outcome Measures

1. All cause mortality [180 days]

Secondary Outcome Measures

1. Neurological outcome according to Cerebral Performance Category (CPC) [at discharge (up to 180 days)]

2. 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

3. Bleedings according to the Bleeding Academic Research Consortium (BARC) criteria [180 days]

   bleeding events evaluated based on the BARC definitions

4. Infectious complications [180 days]

5. Rhythm and conductions disorders [180 days]

   Rhythm and conductions disorders assessed based on ECG telemetry, 12-lead ECG and ECG holter monitoring

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology Department, Dr. A. Jurasz University Hospital	Bydgoszcz	Kujawsko-pomorskie	Poland	85-094

Sponsors and Collaborators

• Jacek Kubica

Investigators

• Principal Investigator: Jacek Kubica, MD, PhD, Collegium Medicum, Nicolaus Copernicus University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Study results

Publications

None provided.

• Responsible Party: Jacek Kubica, Head of Cardiology, Principal investigator, Collegium Medicum w Bydgoszczy
• ClinicalTrials.gov Identifier: NCT02611934
• Other Study ID Numbers: CMUMK202C
• First Posted: Nov 23, 2015
• Last Update Posted: Feb 2, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Coronary Syndrome; Heart Arrest; Syndrome; Hypothermia

Study Results

No Results Posted as of Feb 2, 2021