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

NCT ID: NCT02611934

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-14
• Study Completion Date: 2020-12-31

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.

Conditions

Cardiac Arrest; Acute Coronary Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mild Therapeutic Hypothermia

OHCA survivors with diagnosed or suspected ACS

Group Type: EXPERIMENTAL

Mild Therapeutic Hypothermia (MHT)

Intervention Type: PROCEDURE

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-Mild Therapeutic Hypothermia

OHCA survivors with diagnosed or suspected ACS

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jacek Kubica

OTHER

Sponsor Role: lead

Responsible Party

Jacek Kubica

Head of Cardiology, Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jacek Kubica, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Collegium Medicum, Nicolaus Copernicus University

Locations

Cardiology Department, Dr. A. Jurasz University Hospital

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Countries

Poland

References

Uminska JM, Ratajczak J, Buszko K, Sobczak P, Sroka W, Marszall MP, Adamski P, Steblovnik K, Noc M, Kubica J. Impact of mild therapeutic hypothermia on bioavailability of ticagrelor in patients with acute myocardial infarction after out-of-hospital cardiac arrest. Cardiol J. 2020;27(6):780-788. doi: 10.5603/CJ.a2019.0024. Epub 2019 Feb 25.

Reference Type: DERIVED

PMID: 30799546 (View on PubMed)

Uminska JM, Buszko K, Ratajczak J, Lach P, Pstragowski K, Dabrowska A, Adamski P, Skonieczny G, Manitius J, Kubica J. Comparison of temperature measurements in esophagus and urinary bladder in comatose patients after cardiac arrest undergoing mild therapeutic hypothermia. Cardiol J. 2020;27(6):735-741. doi: 10.5603/CJ.a2018.0115. Epub 2018 Sep 24.

Reference Type: DERIVED

PMID: 30246234 (View on PubMed)

Related Links

https://journals.viamedica.pl/cardiology_journal/article/view/CJ.a2019.0023/47613

Study results

Other Identifiers

CMUMK202C

Identifier Type: -

Identifier Source: org_study_id