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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Therapeutic Hypothermia | Experimental | OHCA survivors with diagnosed or suspected ACS |
|
| no-Mild Therapeutic Hypothermia | No Intervention | OHCA survivors with diagnosed or suspected ACS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mild Therapeutic Hypothermia (MHT) | Procedure | The induction with ice packs and infusion of 0.9% sodium chloride (NaCl) at the temperature of 4ËšC. 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 33ËšC. The rewarming phase will be conducted in an actively controlled manner (0.3ËšC 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. |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 180 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacek Kubica, MD, PhD | Collegium Medicum, Nicolaus Copernicus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Department, Dr. A. Jurasz University Hospital | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-094 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30799546 | Derived | 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. | |
| 30246234 |
| Label | URL |
|---|---|
| Study results | View source |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
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| 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 |
| 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. |