Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT01288105
Status:
TERMINATED
Last Update Posted:
2011-12-28
First Post:
2011-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Optical Coherence Tomography to Determine the Optimal Management of Patients With Drug-eluting Stents Who Need Non-cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 107}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-27', 'studyFirstSubmitDate': '2011-01-20', 'studyFirstSubmitQcDate': '2011-01-31', 'lastUpdatePostDateStruct': {'date': '2011-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiac events', 'timeFrame': '30-days post surgery', 'description': 'composite of cardiac death, myocardial infarction, coronary revascularization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['drug-eluting stents', 'noncardiac surgery'], 'conditions': ['Coronary Stent Occlusion']}, 'descriptionModule': {'briefSummary': 'The specific aim of this proposal is to examine the impact of OCT and IVUS-guided management of patients with prior DES implantation who need major non-cardiac surgery and discontinuation of dual antiplatelet therapy on the perioperative (1 week prior to surgery until 30 days post surgery) incidence of major adverse cardiac events.', 'detailedDescription': 'Patients who receive drug-eluting stents (DES) and subsequently require non-cardiac surgery have increased risk for perioperative stent thrombosis, especially when antiplatelet therapy discontinuation is required. Perioperative administration of a glycoprotein IIb/IIIa inhibitor may decrease the stent thrombosis risk, but it is cumbersome and carries high cost. Stents that have been endothelialized by optical coherence tomography (OCT) are likely to have low risk for perioperative stent thrombosis and therefore intensive management strategies, such as "bridging with a glycoprotein IIb/IIIa inhibitor" would not be required. The current study will assess whether OCT utilization can help optimize the preoperative management of DES patients requiring major non-cardiac surgery.\n\nThe specific aim of this proposal is to examine the impact of OCT and IVUS-guided management of patients with prior DES implantation who need major non-cardiac surgery and discontinuation of dual antiplatelet therapy on the perioperative (1 week prior to surgery until 30 days post surgery) incidence of major adverse cardiac events.\n\nThe hypothesis is that OCT and IVUS-guided treatment will have low incidence (≤10%) of perioperative major adverse cardiac events.\n\nThe specific aim of this proposal is to examine the impact of OCT and IVUS-guided management of patients with prior DES implantation who need major non-cardiac surgery and discontinuation of dual antiplatelet therapy on the perioperative (1 week prior to surgery until 30 days post surgery) incidence of major adverse cardiac events.\n\nThe hypothesis is that OCT and IVUS-guided treatment will have low incidence (≤10%) of perioperative major adverse cardiac events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Need for major non-cardiac surgery requiring discontinuation of dual antiplatelet therapy\n* Agree to participate and provide informed consent\n\nExclusion Criteria:\n\n* Patients who have a creatinine above 2.5 mg/dL (unless they require hemodialysis, in which case they are eligible to participate)\n* Challenging vascular access\n* History of an allergic reaction to glycoprotein IIb/IIIa inhibitors'}, 'identificationModule': {'nctId': 'NCT01288105', 'briefTitle': 'Use of Optical Coherence Tomography to Determine the Optimal Management of Patients With Drug-eluting Stents Who Need Non-cardiac Surgery', 'organization': {'class': 'FED', 'fullName': 'North Texas Veterans Healthcare System'}, 'officialTitle': 'Use of Optical Coherence Tomography to Determine the Optimal Management of Patients With Drug-eluting Stents Who Need Non-cardiac Surgery', 'orgStudyIdInfo': {'id': '10-106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Optical Coherence Tomography', 'description': 'Patients enrolled in the study will undergo optical coherence tomography to evaluate the extent of stent strut coverage.', 'interventionNames': ['Device: Optical coherence tomography']}], 'interventions': [{'name': 'Optical coherence tomography', 'type': 'DEVICE', 'otherNames': ['invasive intracoronary imaging'], 'description': 'Optical coherence tomography will be performed to determine the stent strut coverage. Patients in whom \\>95% of stent struts are covered will not receive perioperative bridging with a glycoprotein IIb/IIIa inhibitors, whereas those with \\<95% stent strut coverage will receive perioperative bridging.', 'armGroupLabels': ['Optical Coherence Tomography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'VA North Texas Healthcare System', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Emmanouil S Brilakis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Texas Veterans Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Texas Veterans Healthcare System', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': 'Teresa D. Moore, IRB administrator', 'oldOrganization': 'VA North Texas Healthcare System'}}}}