Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-03-05 @ 8:00 PM
Study NCT ID:
NCT01897220
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2013-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2013-06-27', 'studyFirstSubmitQcDate': '2013-07-10', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of perioperative complications - especially ischemic or bleeding', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 days', 'description': 'Prevalence of perioperative complications - especially ischemic or bleeding; These complications will be correlated with the pattern of antithrombotic therapy administration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Noncardiac surgery;', 'Perioperative ischemic complications;', 'Perioperative bleeding complications;', 'Antithrombotic therapy;', 'Coronary artery disease;', 'Stent thrombosis;', 'Perioperative infarction.'], 'conditions': ['Surgical Procedure, Non-cardiac', 'Cardiovascular Disease Patients', 'Perioperative Period']}, 'referencesModule': {'references': [{'pmid': '28542316', 'type': 'DERIVED', 'citation': 'Ondrakova M, Motovska Z, Waldauf P, Knot J, Havluj L, Bittner L, Bartoska R, Gurlich R, Krbec M, Dzupa V, Grill R, Widimsky P. Antithrombotic therapy of patients with atrial fibrillation discharged after major non-cardiac surgery. 1-year follow-up. Sub-analysis of PRAGUE 14 study. PLoS One. 2017 May 24;12(5):e0177519. doi: 10.1371/journal.pone.0177519. eCollection 2017.'}], 'seeAlsoLinks': [{'url': 'http://link.springer.com/article/10.1007/s12471-014-0575-3', 'label': 'Main manuscript'}, {'url': 'http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5443499/', 'label': 'Subanalysis'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to analyze the present use of antithrombotic therapy on a large cohort of consecutive cardiacs undergoing non-cardiac surgery. If even and for how long the medication was discontinued, if any other antithrombotic therapy was used in the perioperative period and prevalence of perioperative complications - especially ischemic or bleeding. These complications will be correlated with the pattern of antithrombotic therapy administration. Working hypothesis is to obtain a large database of unselected cohort of consecutive patients for mapping of this practically important, but in the evidence-based medicine, still neglected problem.', 'detailedDescription': 'This project will closely describe (prospective registry) the present situation (anti-thrombotic medication, prevalence of bleeding and ischemic complication) in a large consecutive cohort of non-selected cardiac patients, who are undergoing non-cardiac surgery.\n\nPatients have to meet all three inclusion criteria: (1) Any kind of non-cardiac surgery (acute or elective) performed under general or neuraxial anaesthesia in four surgical departments - General surgery, Orthopedics-Trauma, Urology and Neurosurgery. (2) History of cardiac disease with risk of arterial, intracardiac or vein thrombosis or embolism. (3) Signed Informed consent. All operated patients who meet the inclusion criteria will get enrolled, i.e. all consecutive cardiacs, who signed Informed consent.\n\nBaseline clinical indicators, chronic and perioperative medication, ECG, laboratory tests and all complications (especially ischemic and bleeding) will be registered.\n\nParticipants will be followed for the duration of hospital stay, an expected average of 10 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Unselected cohort of consecutive patients undergoing non-cardiac surgery in four surgical clinics of the University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any kind of non-cardiac surgery (acute or elective) performed under general or neuraxial anaesthesia in four surgical departments - General surgery, Orthopedics-Trauma, Urology and Neurosurgery.\n* History of cardiovascular disease with risk of arterial, intracardiac or vein thrombosis or embolism. (3) Signed Informed consent.\n\nExclusion Criteria:\n\n* There are no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT01897220', 'acronym': 'PRAGUE-14', 'briefTitle': 'Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients : PRAGUE 14 Study', 'orgStudyIdInfo': {'id': 'NT/11506-6'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'University Hospital Patients', 'description': 'Consecutive patients with cardiovascular disease(s) undergoing non-cardiac surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10034', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Cardiocentre, Univ. Hospital Kralovske Vinohrady', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '10034', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Cardiocentre, Univ. Hospital Královské Vinohrady', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Petr Widimsky, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiocentre, Univ. Hospital Královské Vinohrady, Prague, Czech Rep.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Czech Republic', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Petr Widimsky, MD', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}