Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-06 @ 9:47 AM
Study NCT ID:
NCT02611934
Status:
TERMINATED
Last Update Posted:
2021-02-02
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'whyStopped': 'Due to insufficient enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2015-11-18', 'studyFirstSubmitQcDate': '2015-11-19', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '180 days'}], 'secondaryOutcomes': [{'measure': 'Neurological outcome according to Cerebral Performance Category (CPC)', 'timeFrame': 'at discharge (up to 180 days)'}, {'measure': 'Early stent thrombosis', 'timeFrame': '30 days', 'description': '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'}, {'measure': 'Bleedings according to the Bleeding Academic Research Consortium (BARC) criteria', 'timeFrame': '180 days', 'description': 'bleeding events evaluated based on the BARC definitions'}, {'measure': 'Infectious complications', 'timeFrame': '180 days'}, {'measure': 'Rhythm and conductions disorders', 'timeFrame': '180 days', 'description': 'Rhythm and conductions disorders assessed based on ECG telemetry, 12-lead ECG and ECG holter monitoring'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest', 'Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '30799546', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '30246234', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://journals.viamedica.pl/cardiology_journal/article/view/CJ.a2019.0023/47613', 'label': 'Study results'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Survivor of OHCA\n* Sustained return of spontaneous circulation (ROSC) for more than 20 minutes after resuscitation\n* Unconsciousness with a score of ≤8 on the Glasgow Coma Scale after ROSC\n* Shockable initial rhythm\n* Diagnosis or suspicion of ACS\n\nExclusion Criteria:\n\n* Unwitnessed OHCA\n* Obvious or suspected pregnancy\n* Known serious infection/sepsis before OHCA\n* Known bleeding diathesis\n* Confirmed or suspected internal bleeding\n* Confirmed or suspected acute stroke\n* Confirmed or suspected cerebral injury\n* Known serious neurological dysfunction (CPC≤4) before OHCA\n* Known serious disease making 180 days of survival unlikely\n* Hemodynamic instability with systolic blood pressure \\<65 mmHg despite treatment\n* Time delay from ROSC to MTH induction \\> 240 min.\n* Asystole or pulseless electrical activity (PEA) as the initial rhythm\n* Initial body temperature \\<30°C'}, 'identificationModule': {'nctId': 'NCT02611934', 'acronym': 'UNICORN', 'briefTitle': 'Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With PCI', 'organization': {'class': 'OTHER', 'fullName': 'Collegium Medicum w Bydgoszczy'}, 'officialTitle': 'Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'CMUMK202C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild Therapeutic Hypothermia', 'description': 'OHCA survivors with diagnosed or suspected ACS', 'interventionNames': ['Procedure: Mild Therapeutic Hypothermia (MHT)']}, {'type': 'NO_INTERVENTION', 'label': 'no-Mild Therapeutic Hypothermia', 'description': 'OHCA survivors with diagnosed or suspected ACS'}], 'interventions': [{'name': 'Mild Therapeutic Hypothermia (MHT)', 'type': 'PROCEDURE', 'description': "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.", 'armGroupLabels': ['Mild Therapeutic Hypothermia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85-094', 'city': 'Bydgoszcz', 'state': 'Kuyavian-Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Cardiology Department, Dr. A. Jurasz University Hospital', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}], 'overallOfficials': [{'name': 'Jacek Kubica, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Collegium Medicum, Nicolaus Copernicus University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jacek Kubica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Cardiology, Principal investigator', 'investigatorFullName': 'Jacek Kubica', 'investigatorAffiliation': 'Collegium Medicum w Bydgoszczy'}}}}