Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-03-21 @ 10:09 AM
Study NCT ID:
NCT02918500
Status:
TERMINATED
Last Update Posted:
2022-01-05
First Post:
2016-09-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Pre-op NRT on Peri-operative Complications and Long-term Abstinence: A Pilot Trial in Patients Undergoing CABG Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'apipe@ottawaheart.ca', 'phone': '613-696-7000', 'title': 'Dr. Andrew Pipe', 'organization': 'University of Ottawa Heart Institute'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study was terminated early due to recruitment challenges; only 4 participants were recruited. The data for these 4 participants will not be analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected over a period of 8 months (recruitment start to recruitment termination). Participants were monitored for adverse events during their 3 week intervention period.', 'description': 'Adverse events were reported by the participants to the Research Coordinator. Participants were directly asked about adverse events during each study contact.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants will receive 3 weeks of inactive NRT patches.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active', 'description': 'Participants will receive 3 weeks of active NRT patches\n\nNicoderm Patch: Nicotine replacement therapy patch', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Carbon Monoxide (CO) Confirmed Abstinence at the Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will receive 3 weeks of inactive NRT patches.'}, {'id': 'OG001', 'title': 'Active', 'description': 'Participants will receive 3 weeks of active NRT patches\n\nNicoderm Patch: Nicotine replacement therapy patch'}], 'timeFrame': 'At the time of CABG surgery (will vary with all participants based on their surgical date) and at each follow up visit (1 month and 6 month post-op)', 'description': 'To determine if pre-operative, (short-term) NRT, 1 to 3 weeks before surgery, improves the long-term quit rates among smokers undergoing elective CABG surgery', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated due to recruitment challenges. Only 4 participants were recruited and therefore there was not enough data to warrant analysis.'}, {'type': 'SECONDARY', 'title': 'The Effect of Pre-operative NRT on Perceived Stress and Symptoms of Nicotine Withdrawal at the Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will receive 3 weeks of inactive NRT patches.'}, {'id': 'OG001', 'title': 'Active', 'description': 'Participants will receive 3 weeks of active NRT patches'}], 'timeFrame': 'At the time of surgery and each follow up visit (1 & 6 months post-op)', 'description': 'Measured by the perceived stress scale (PSS-14)', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to a small sample size recruited for this trial, the follow up data was not assessed within either group'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Impact of Pre-operative Cessation on Peri-operative Complications Such as Infection Rates, Respiratory Failure, Myocardial Infarction, Stroke, Sepsis, Shock and Prolonged Hospital Stay.', 'timeFrame': 'assessed at the 1 and 6 month post-op follow up visits', 'description': 'Participants will be asked about any post-operative complications and a retrospective chart review will be completed for all participants.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants will receive 3 weeks of inactive NRT patches.'}, {'id': 'FG001', 'title': 'Active', 'description': 'Participants will receive 3 weeks of active NRT patches\n\nNicoderm Patch: Nicotine replacement therapy patch'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants will receive 3 weeks of inactive NRT patches.'}, {'id': 'BG001', 'title': 'Active', 'description': 'Participants will receive 3 weeks of active NRT patches\n\nNicoderm Patch: Nicotine replacement therapy patch'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000', 'lowerLimit': '54', 'upperLimit': '76'}, {'value': '70', 'groupId': 'BG001', 'lowerLimit': '57', 'upperLimit': '83'}, {'value': '68.5', 'groupId': 'BG002', 'lowerLimit': '54', 'upperLimit': '83'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2018-10-26', 'size': 301276, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-08-05T16:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Due to recruitment challenges.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-03', 'studyFirstSubmitDate': '2016-09-06', 'resultsFirstSubmitDate': '2021-09-27', 'studyFirstSubmitQcDate': '2016-09-26', 'lastUpdatePostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-03', 'studyFirstPostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The Impact of Pre-operative Cessation on Peri-operative Complications Such as Infection Rates, Respiratory Failure, Myocardial Infarction, Stroke, Sepsis, Shock and Prolonged Hospital Stay.', 'timeFrame': 'assessed at the 1 and 6 month post-op follow up visits', 'description': 'Participants will be asked about any post-operative complications and a retrospective chart review will be completed for all participants.'}], 'primaryOutcomes': [{'measure': 'Carbon Monoxide (CO) Confirmed Abstinence at the Time of Surgery', 'timeFrame': 'At the time of CABG surgery (will vary with all participants based on their surgical date) and at each follow up visit (1 month and 6 month post-op)', 'description': 'To determine if pre-operative, (short-term) NRT, 1 to 3 weeks before surgery, improves the long-term quit rates among smokers undergoing elective CABG surgery'}], 'secondaryOutcomes': [{'measure': 'The Effect of Pre-operative NRT on Perceived Stress and Symptoms of Nicotine Withdrawal at the Time of Surgery', 'timeFrame': 'At the time of surgery and each follow up visit (1 & 6 months post-op)', 'description': 'Measured by the perceived stress scale (PSS-14)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Bypass Surgery (CABG)', 'Nicotine Replacement Therapy (NRT)'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'This study will determine whether or not patients who use a Nicotine Replacement Therapy (NRT) patch prior to their by-pass surgery are more likely to be smoke-free 6 months after their surgery and have fewer post-operative complications', 'detailedDescription': 'The aim of this project is to\n\n1. To determine if pre-operative, (short-term) NRT, 1 to 3 weeks before surgery, improves the long-term quit rates among smokers undergoing elective CABG surgery.\n2. To determine the effect of pre-operative NRT on perceived stress and symptoms of nicotine withdrawal at the time of surgery.\n3. To assess, retroactively, the impact of pre-operative cessation on peri-operative complications such as infection rates, respiratory failure, myocardial infarction, stroke, sepsis, shock and prolonged hospital stay.\n\nWe therefore hypothesize that if NRT is given to smokers during the pre-admission period (1-3 weeks prior to surgery), they are more likely to be biochemically abstinent from cigarette smoking 6 months after hospitalization and will experience fewer peri-operative complications\n\nTo assess these measures, we have designed a single site, double-blinded randomized controlled trial at the University of Ottawa Heart Institute (UOHI). Patients who are identified as a smoker at their initial visit to the PAU will undergo a baseline assessment and be randomly assigned (1:1) to either active or placebo 21mg NRT patch. They will wear the patch from that baseline visit until the day of their surgery at UOHI. Following their surgery, they will receive a follow up phone call at 1 and 6 months post-discharge. They will complete a series of short questionnaires to assess their smoking status, stress levels and nicotine withdrawal symptoms. Those who identify themselves as being smoke-free will be asked to complete a carbon monoxide breathing test to chemically validate their smoking status. The study protocol will be reviewed by the Research Ethics board at UOHI and all participants will provide written informed consent prior to undertaking any study activities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is currently smoking \\>5 cigarettes/day for the past 30 days; there is no evidence that NRT is useful in those who smoke \\<5cpd.\n2. Patient is able to participate and willing to provide informed consent; participants will need to follow directions and adhere to the medication usage instructions as outlined in the informed consent document.\n3. Patients is willing to be contacted by phone for follow up at 1 month and 6 months post-discharge; these time points will assess our final outcome of cessation at 6 months post-discharge.\n\nExclusion Criteria:\n\n1. Patient is scheduled for surgery in \\< 7 days; most patients need to be using NRT consistently for 2 weeks for it to be fully effective.\n2. Patient is currently using a smoking cessation product (i.e. nicotine containing patch, gum, inhaler, lozenge, spray or nicotine containing electronic cigarette, varenicline, buproprion) or has used a smoking cessation aid consistently for more than 72 consecutive hours with the intent to reduce cigarette consumption or quit smoking within 30 days of the baseline Pre-admission Unit (PAU) visit; this will ensure the effects of the study patches will be assessed without any contamination from other cessation products.\n3. Patient is willing to refrain from using any other cessation products (nicotine containing patch, gum, inhaler, lozenge, spray, nicotine containing electronic cigarette, varenicline, buproprion) prior to surgery; this will allow us to track the usage and side effects with the study patches.\n4. Patient is allergic to the adhesive on the nicotine replacement therapy patch.\n5. Patient is unable to read and understand English or French; study materials will only be supplied in these two languages.'}, 'identificationModule': {'nctId': 'NCT02918500', 'briefTitle': 'Effect of Pre-op NRT on Peri-operative Complications and Long-term Abstinence: A Pilot Trial in Patients Undergoing CABG Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Heart Institute Research Corporation'}, 'officialTitle': 'Effect of Pre-operative Nicotine Replacement Therapy on Peri-operative Complications and Long-term Abstinence: A Pilot Placebo-controlled Trial in Patients Undergoing Coronary Artery Bypass Surgery (CABG)', 'orgStudyIdInfo': {'id': '20160696-01H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Placebo', 'description': 'Participants will receive 3 weeks of inactive NRT patches.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'Participants will receive 3 weeks of active NRT patches', 'interventionNames': ['Drug: Nicoderm Patch']}], 'interventions': [{'name': 'Nicoderm Patch', 'type': 'DRUG', 'description': 'Nicotine replacement therapy patch', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y4W7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Andrew Pipe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Heart Institute Research Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}