Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-31 @ 4:58 AM
Study NCT ID:
NCT02309151
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2014-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1006}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2014-11-17', 'studyFirstSubmitQcDate': '2014-12-02', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30 day survival', 'timeFrame': '30 days', 'description': 'Follow up will be performed at 30 days, telephone call or visit.'}], 'secondaryOutcomes': [{'measure': 'Survival with good neurological function', 'timeFrame': '30 days', 'description': '30-day survival and a follow up of health status, functional outcome associated to cerebral performance and general functional outcome/activities of daily living'}, {'measure': 'Survival at discharge from ICU (individual for each subject) and at 6-months', 'timeFrame': 'At discharge from ICU, an expected average of 3-30 days and at 6-months', 'description': 'Recorded in the e-CRF (electronic Case Report Form)'}, {'measure': 'Survival with good neurological function at discharge from ICU and 6-months', 'timeFrame': 'At discharge from ICU, an expected average of 3-30 days and at 6-months', 'description': 'Survival with good neurological function at discharge and at 6-months. Assessing functional outcome associated to cerebral performance and general functional outcome/activities of daily living and also global functional outcome, independent living and social reintegration at 6-months'}, {'measure': 'Cardiac function', 'timeFrame': '72 hours and at 6 months', 'description': 'Measured with echocardiography'}, {'measure': 'Follow up of neurological function at 6-months', 'timeFrame': 'Measured at 6 months', 'description': 'A 6 month follow up of neurological function will be assessed by validated screening battery in OHCA (Out of Hospital Cardiac Arrest) patients in general functional outcome, activities of daily living, cognitive functioning, attention, anxiety and depression, fatigue, cardiac disease specific health and care giver burden.'}, {'measure': 'Hemodynamic parameters (urine output, highest lactate and vasopressor/inotropic support)', 'timeFrame': 'During ICU care (maximum of 7 days)', 'description': 'Parameters measured daily during ICU care'}, {'measure': 'ECG findings compared to findings at coronary angiography', 'timeFrame': 'During hospital stay up to a maximum of 6-months', 'description': 'Primary ECG, performed in the pre-hospital setting or at the emergency department, will be compared with findings at coronary angiography intervention (performed immediately or later during hospital stay depending on randomisation)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Out-of-Hospital Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '32154359', 'type': 'DERIVED', 'citation': 'Elfwen L, Lagedal R, Rubertsson S, James S, Oldgren J, Olsson J, Hollenberg J, Jensen U, Ringh M, Svensson L, Nordberg P. Post-resuscitation myocardial dysfunction in out-of-hospital cardiac arrest patients randomized to immediate coronary angiography versus standard of care. Int J Cardiol Heart Vasc. 2020 Mar 2;27:100483. doi: 10.1016/j.ijcha.2020.100483. eCollection 2020 Apr.'}, {'pmid': '31028826', 'type': 'DERIVED', 'citation': 'Elfwen L, Lagedal R, Nordberg P, James S, Oldgren J, Bohm F, Lundgren P, Rylander C, van der Linden J, Hollenberg J, Erlinge D, Cronberg T, Jensen U, Friberg H, Lilja G, Larsson IM, Wallin E, Rubertsson S, Svensson L. Direct or subacute coronary angiography in out-of-hospital cardiac arrest (DISCO)-An initial pilot-study of a randomized clinical trial. Resuscitation. 2019 Jun;139:253-261. doi: 10.1016/j.resuscitation.2019.04.027. Epub 2019 Apr 24.'}, {'pmid': '29447784', 'type': 'DERIVED', 'citation': 'Lagedal R, Elfwen L, James S, Oldgren J, Erlinge D, Ostlund O, Wallin E, Larsson IM, Lilja G, Cronberg T, Rubertsson S, Nordberg P. Design of DISCO-Direct or Subacute Coronary Angiography in Out-of-Hospital Cardiac Arrest study. Am Heart J. 2018 Mar;197:53-61. doi: 10.1016/j.ahj.2017.11.009. Epub 2017 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of this prospective, randomized study is to investigate whether acute coronary angiography (within 120 minutes) with a predefined strategy for revascularization, will improve 30-day survival in patients with out of hospital cardiac arrest with no signs of ST-elevation on ECG after Restoration of Spontaneous Circulation (ROSC). The patients will be randomized to a strategy of immediate coronary angiography within 120 minutes or to a strategy of delayed angiography that may be performed three days after the cardiac arrest.', 'detailedDescription': 'The study is a prospective randomized open label multicenter study with a registry follow up in which patients with out of hospital cardiac arrest without ST-elevation on their first ECG will be randomized to either a strategy of immediate coronary angiography (treatment group) with possible coronary intervention or a strategy of delayed coronary angiography (control group). The study will include in total 1006 patients with Restoration of Spontaneous Circulation (ROSC). Randomization will be done via a web-based module after ECG is taken at the first medical contact but no later than after arrival at the emergency room. Coronary angiography should be performed within 120 minutes from randomization in the immediate angiography group. In the delayed angiography group, angiography with possible coronary intervention will be performed at the discretion of the interventional cardiologist and should preferably not be performed until three days after the cardiac arrest. This strategy is in accordance with standard practice. In case of recurrent chest pain, ST elevation, circulatory instability or cardiogenic shock, cross over to early angiography may occur. The quality of life and health economics will be evaluated at 6 months. The patients will undergo extensive neurocognitive tests and health instruments, these will be analyzed and presented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Witnessed out of hospital cardiac arrest\n* Restoration of Spontaneous Circulation (ROSC) \\>20 minutes\n* Coronary angiography is expected to be performed within 120 minutes from inclusion and randomization at hospital\n\nExclusion Criteria:\n\n* Patient age \\<18 years\n* Obvious extracardiac genesis of cardiac arrest such as trauma, hemorrhagic shock, and / or asphyxia (eg drowning, suffocation, hanging, exposure to fire smoke)\n* Terminally ill patients with a life expectancy of less than 1 year\n* Patients with ST-elevation\n* Known pregnancy\n* Patient awake GCS \\>8 (Glasgow Coma Scale)'}, 'identificationModule': {'nctId': 'NCT02309151', 'acronym': 'DISCO', 'briefTitle': 'Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest - a Prospective, Randomized Study', 'orgStudyIdInfo': {'id': 'DSC001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate coronary angiography', 'description': 'Immediate coronary angiography for out of hospital cardiac arrest patients with no signs of ST elevation on their first ECG after ROSC', 'interventionNames': ['Procedure: Immediate coronary angiography']}, {'type': 'NO_INTERVENTION', 'label': 'Not immediate coronary angiography', 'description': 'Coronary angiography with possible coronary intervention may be performed at the discretion of the interventional cardiologist and should preferably not be performed until three days after the cardiac arrest. This strategy is in accordance with standard practice.'}], 'interventions': [{'name': 'Immediate coronary angiography', 'type': 'PROCEDURE', 'description': 'Immediate coronary angiography for out of hospital cardiac arrest patients with no signs of ST elevation on their first ECG after ROSC', 'armGroupLabels': ['Immediate coronary angiography']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalborg', 'status': 'TERMINATED', 'country': 'Denmark', 'facility': 'Aalborg University hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Christian Juhl Terkelsen', 'role': 'CONTACT'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lisette Okkels Jensen', 'role': 'CONTACT'}], 'facility': 'Odense University hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'José Henriques', 'role': 'CONTACT'}], 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Dordrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Rohit Oemrawsingh', 'role': 'CONTACT'}], 'facility': 'Albert Schweitzer Hospital', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'city': 'Eindhoven', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Luuk Otterspoor', 'role': 'CONTACT'}], 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Emmen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Rutger Anthonio', 'role': 'CONTACT'}], 'facility': 'Treant Hospital', 'geoPoint': {'lat': 52.77917, 'lon': 6.90694}}, {'city': 'Heerlen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'R van der Vleugel', 'role': 'CONTACT'}], 'facility': 'Zuyderland Hospital', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'city': 'Nieuwegein', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jan-Peter Van Kuijk', 'role': 'CONTACT'}], 'facility': 'Antonius Hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Judith Bonnes', 'role': 'CONTACT'}], 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'The Hague', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Dirk Van Der Heijden', 'role': 'CONTACT'}], 'facility': 'Haaglanden Medisch Centrum', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Peter Lundgren', 'role': 'CONTACT'}], 'facility': 'Sahlgrenska Universitetssjukhuset', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Huddinge', 'status': 'TERMINATED', 'country': 'Sweden', 'facility': 'Karolinska Universitetssjukhuset', 'geoPoint': {'lat': 59.23705, 'lon': 17.98192}}, {'city': 'Lund', 'status': 'TERMINATED', 'country': 'Sweden', 'facility': 'Skånes Universitetssjukhus', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Malmo', 'status': 'TERMINATED', 'country': 'Sweden', 'facility': 'Skåne Universitetssjukhus', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Örebro', 'status': 'TERMINATED', 'country': 'Sweden', 'facility': 'Örebro Universitetssjukhus', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'city': 'Solna', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Liyew Desta', 'role': 'CONTACT'}], 'facility': 'Karolinska Universitetssjukhuset', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}, {'city': 'Stockholm', 'status': 'TERMINATED', 'country': 'Sweden', 'facility': 'Danderyd Sjukhus', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Ludig Elfwen', 'role': 'CONTACT'}], 'facility': 'Södersjukhuset AB', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Umeå', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Peter Gottfridsson', 'role': 'CONTACT'}], 'facility': 'Umeå Universitetssjukhus', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'zip': '75185', 'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Sten Rubertsson', 'role': 'CONTACT', 'email': 'sten.rubertsson@akademiska.se', 'phone': '+46708693996'}], 'facility': 'Uppsala University hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Sten Rubertsson Rubertsson, Md,PhD', 'role': 'CONTACT', 'email': 'sten.rubertsson@akademiska.se', 'phone': '+46708693996'}, {'name': 'Stefan James, Md,PhD', 'role': 'CONTACT', 'email': 'stefan.james@ucr.uu.se'}], 'overallOfficials': [{'name': 'Sten Rubertsson, Md,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala Universtiy hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}