Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-03-26 @ 10:12 AM
Study NCT ID:
NCT02701504
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2014-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Undiagnosed Sleep Apnea and Bypass OperaTion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-25', 'studyFirstSubmitDate': '2014-09-23', 'studyFirstSubmitQcDate': '2016-03-07', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac and Cerebrovascular Events', 'timeFrame': 'Average of 2 years after CABG', 'description': 'The number of patients with cardiac mortality, stroke, myocardial infarction, or repeat revascularization'}], 'secondaryOutcomes': [{'measure': 'Other Cardiac and Cerebrovascular Events', 'timeFrame': 'Average of 2 years after CABG', 'description': 'Sudden cardiac death or resuscitated cardiac arrest, all-cause mortality, hospitalization for heart failure,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep apnea', 'coronary artery bypass grafting', 'outcomes'], 'conditions': ['Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '38163943', 'type': 'DERIVED', 'citation': 'Teo YH, Yong CL, Ou YH, Tam WW, Teo YN, Koo CY, Kojodjojo P, Lee CH. Obstructive sleep apnea and temporal changes in cardiac repolarization in patients undergoing coronary artery bypass grafting. J Clin Sleep Med. 2024 Jan 1;20(1):49-55. doi: 10.5664/jcsm.10786.'}, {'pmid': '33303900', 'type': 'DERIVED', 'citation': 'Aung AT, Koo CY, Tam WW, Chen Z, Kristanto W, Sim HW, Kojodjojo P, Kofidis T, Lee CH. Sleep apnea and diabetes mellitus are independently associated with cardiovascular events and hospitalization for heart failure after coronary artery bypass grafting. Sci Rep. 2020 Dec 10;10(1):21664. doi: 10.1038/s41598-020-78700-9.'}, {'pmid': '32423904', 'type': 'DERIVED', 'citation': 'Koo CY, Aung AT, Chen Z, Kristanto W, Sim HW, Tam WW, Gochuico CF, Tan KA, Kang GS, Sorokin V, Ong PJL, Kojodjojo P, Richards AM, Tan HC, Kofidis T, Lee CH. Sleep apnoea and cardiovascular outcomes after coronary artery bypass grafting. Heart. 2020 Oct;106(19):1495-1502. doi: 10.1136/heartjnl-2019-316118. Epub 2020 May 18.'}]}, 'descriptionModule': {'briefSummary': 'Sleep apnea is a prevalent disorder in patients with coronary artery disease. Previous studies suggested sleep apnea was associated with coronary plaque burden and future adverse cardiovascular events after percutaneous coronary intervention. In the SABOT study, the investigators used a FDA-approved portable sleep device to diagnose sleep apnea, and evaluate the relationship between sleep apnea and cardiovascular outcomes after non-urgent coronary artery bypass surgery.', 'detailedDescription': 'The SABOT Study is an observational study designed to study the impact of sleep apnea on cardiovascular outcomes after non-urgent coronary artery bypass surgery (CABG). Patients between the ages of 18 and 90 who are scheduled undergo an non-urgent CABG were eligible for the study\n\nThe recruited patients participants were scheduled to undergo a hospital-based overnight sleep study using a US Food and Drug Administration-approved portable monitoring devices: the Watch-PAT (Itamar Medical, Caesarea, Israel). Watch-PAT is a four-channel unattended sleep monitoring device that measures peripheral arterial tone (PAT), pulse oximetry, heart rate, and actigraphy from a built-in actigraph. Respiratory events are identified by digital vasoconstriction mediated by α-adrenergic receptors that are sensitive to surges in sympathetic activity. Respiratory events are considered to be present when one of the following three criteria was met: a reduction in PAT amplitude with an acceleration of the pulse rate or an increase in wrist activity; a reduction in PAT amplitude with ≥3% oxyhemoglobin desaturation; and ≥4% oxyhemoglobin desaturation only. Although manual scoring and editing of the Watch-PAT signals are possible, we adopted results generated by the device algorithm alone with no intervention by the operator. The diagnosis of sleep apnea is confirmed if the AHI was greater than 15 events/h.\n\nEnd Points The pre-specified primary end point is a major adverse cardiac and cerebrovascular event (MACCE), defined as a composite of cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, and repeat revascularization.\n\nThe secondary end point comprised sudden cardiac death or resuscitated cardiac arrest, all-cause mortality, and hospitalization for heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with coronary artery disease scheduled to undergo coronary artery bypass surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with coronary artery disease scheduled to undergo non-urgent coronary artery bypass surgery\n\nExclusion Criteria:\n\n* Known sleep apnea on CPAP therapy\n* Cardiogenic shock on mechanical hemodynamic support\n* Intubated on mechanical ventilation\n* Heart failure on oxygen therapy\n* Long -term alpha blocker therapy\n* Severe chronic pulmonary disease\n* Recurrent malignant arrhythmia\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02701504', 'acronym': 'SABOT', 'briefTitle': 'Undiagnosed Sleep Apnea and Bypass OperaTion', 'organization': {'class': 'OTHER', 'fullName': 'National University of Singapore'}, 'officialTitle': 'Association Between Sleep Apnea and Occurrence of Major Adverse Cardiovascular Events After Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': 'SABOT Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sleep apnea group', 'description': 'The patients who are found to have sleep apnea based on the results of the portable sleep study'}, {'label': 'Non sleep apnea group', 'description': 'The patients who are found to have no sleep apnea based on the results of the portable sleep study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '119228', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Heart Centre, Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Chi-Hang Lee, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National University of Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chi-Hang Lee', 'investigatorAffiliation': 'National University of Singapore'}}}}