Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 4:47 AM
Study NCT ID:
NCT00928460
Status:
WITHDRAWN
Last Update Posted:
2013-07-31
First Post:
2009-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Preoperative Electrocardiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-30', 'studyFirstSubmitDate': '2009-06-25', 'studyFirstSubmitQcDate': '2009-06-25', 'lastUpdatePostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac death or perioperative myocardial infarction', 'timeFrame': '2 days postoperatively'}], 'secondaryOutcomes': [{'measure': 'Other major cardiovascular complications', 'timeFrame': '2 days postoperatively'}, {'measure': 'Death from other causes', 'timeFrame': '2 days postoperatively'}, {'measure': 'Long term quality of life', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Electrocardiogram', 'Electrocardiography', 'Perioperative care', 'Preoperative care', 'Preanesthesia Evaluation', 'Acute Coronary Syndrome', 'Postoperative Myocardial Infarction', 'Myocardial ischaemia', 'Postoperative Cardiac Death', 'Intraoperative complications', 'Postoperative complications', 'Cost-effectiveness analysis'], 'conditions': ['Acute Coronary Syndrome', 'Myocardial Infarction', 'Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '17667491', 'type': 'BACKGROUND', 'citation': 'van Klei WA, Bryson GL, Yang H, Kalkman CJ, Wells GA, Beattie WS. The value of routine preoperative electrocardiography in predicting myocardial infarction after noncardiac surgery. Ann Surg. 2007 Aug;246(2):165-70. doi: 10.1097/01.sla.0000261737.62514.63.'}]}, 'descriptionModule': {'briefSummary': 'A preoperative electrocardiogram (ECG) is nearly routinely performed by anesthesiologists in elderly non-cardiac surgery patients as part of pre-anesthesia evaluation. However, the added value of this routine ECG beyond patient history and physical examination is questionable. The ECGtrial will investigate the efficacy of routine preoperative electrocardiography in patients undergoing non-cardiac surgery.', 'detailedDescription': 'Objective:\n\nA routine ECG is performed as part of the standard diagnostic workup before non-cardiac surgery. However, the added value of this test beyond patient history and physical examination is questionable. The proposed study therefore aims to determine whether preoperative assessment without ECG is more cost-effective.\n\nStudy design:\n\nProspective stepped wedge design multicenter trial including 40,000 patients.\n\nStudy population:\n\nAll patients aged over 60 years, or younger patients with cardiovascular risk factors, scheduled for non-cardiac surgery with an expected postoperative hospital stay of at least 2 days.\n\nIntervention:\n\nA new preoperative assessment strategy without routine ECG. Initially, all patients in the participating centers are assessed following the regular strategy (with routine ECG). The new strategy (without routine ECG) is rolled out to the participating hospitals sequentially. At the end of the trial all participating centers will use the new preoperative strategy.\n\nOutcome measures:\n\nThe primary outcome measure is cardiac death or perioperative myocardial infarction. The latter will be verified by Troponin values at postoperative day 1 and 2. If the Troponin levels are elevated the presence of myocardial infarction will be evaluated by a consulting cardiologist. Secondary outcomes are other major cardiovascular complications, death from other causes within 2 days of surgery, and long term quality of life. To determine cost-effectiveness of the strategy without ECG all pre- and postoperative referrals and interventions are taken into account.\n\nSample size calculation:\n\nWe expect no increase in the primary outcome in the intervention group. To rule out an 0.5% increase (from 3% to 3.5%) in the intervention group, the inclusion of 36,504 patients is required (level of confidence: 0.95; power: 0.80). To compensate for expected 10% loss-to-follow up, 40,000 patients will be randomized.\n\nEconomic evaluation:\n\nA cost-effectiveness analysis will be conducted when the increase in primary outcome is between 0.0 and 0.5%. If the intervention results in a lower prevalence of the primary outcome, no cost-effectiveness analysis is performed as the health and cost outcomes point in the same, advantageous, direction. An increase of more than 0.5% is not considered acceptable from a clinical point of view.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients aged over 60 years, or younger patients with cardiovascular risk factors, scheduled for non-cardiac surgery with an expected postoperative hospital length of stay of at least 2 days.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients aged 60 years or older scheduled for noncardiac surgery with an expected hospital length of stay of at least 2 days\n* Patients aged under 60 years but with risk factors for cardiovascular disease scheduled for noncardiac surgery with an expected hospital length of stay of at least 2 days\n\nExclusion Criteria:\n\n* Patients refusing informed consent for obtaining blood samples (troponin measurement) at the first two days after surgery\n* Patients refusing participation in long-term clinical and Quality of Life measurements'}, 'identificationModule': {'nctId': 'NCT00928460', 'briefTitle': 'Efficacy of Preoperative Electrocardiography', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'The Efficacy of Routine Preoperative Electrocardiography in Patients Undergoing Non-cardiac Surgery', 'orgStudyIdInfo': {'id': 'ECGtrial'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Regular preanesthesia evaluation', 'description': 'Patients are evaluated by the anesthesiologist according to current protocol, including routine preoperative ECG.'}, {'label': 'New preanesthesia evaluation', 'description': 'Patients are evaluated by the anesthesiologist according to a new protocol, in which a routine preoperative ECG is no longer provided.', 'interventionNames': ['Procedure: Removal of preoperative electrocardiogram']}], 'interventions': [{'name': 'Removal of preoperative electrocardiogram', 'type': 'PROCEDURE', 'description': 'A new preanesthesia evaluation strategy without routine ECG. Initially, all patients in the participating centers are assessed following the regular strategy (with routine ECG). The new strategy (without routine ECG) is rolled out to the participating hospitals sequentially. At the end of the trial all participating centers will use the new preoperative strategy.', 'armGroupLabels': ['New preanesthesia evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3508 GA', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Cor J Kalkman, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'UMC Utrecht'}, {'name': 'Wilton A van Klei, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}, {'name': 'Jurgen C de Graaff, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Wilton A van Klei', 'investigatorAffiliation': 'UMC Utrecht'}}}}