Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-02 @ 3:47 AM
Study NCT ID:
NCT01839058
Status:
COMPLETED
Last Update Posted:
2018-11-26
First Post:
2013-04-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'keith.mcintosh@sjhc.london.on.ca', 'phone': '519-646-6100', 'title': 'Keith McIntosh', 'phoneExt': '61312', 'organization': 'Western University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Non Cardiac Chest Pain Patients', 'description': 'Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.\n\nEsophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Controls', 'description': 'Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.\n\nEsophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Esophageal Length With Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non Cardiac Chest Pain Patients', 'description': 'Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.\n\nEsophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.'}, {'id': 'OG001', 'title': 'Healthy Controls', 'description': 'Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.\n\nEsophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Length at T= 20 minutes - Baseline (T=0)', 'description': 'Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Esophageal Length at Symptom Onset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non Cardiac Chest Pain Patients', 'description': 'Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.\n\nEsophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.'}, {'id': 'OG001', 'title': 'Healthy Controls', 'description': 'Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.\n\nEsophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.'}], 'timeFrame': '20 minutes', 'description': 'Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms', 'reportingStatus': 'POSTED', 'populationDescription': 'As pre-specified in the protocol, this Outcome Measure was intended to be analyzed only if a correlation was found between esophageal shortening and symptom production. Thus data was not collected.'}, {'type': 'SECONDARY', 'title': 'Esophageal Length at Maximal Symptom Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non Cardiac Chest Pain Patients', 'description': 'Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.\n\nEsophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.'}, {'id': 'OG001', 'title': 'Healthy Controls', 'description': 'Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.\n\nEsophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.'}], 'timeFrame': '20 minutes', 'description': 'Mean length of esophagus at peak patient reported symptom intensity with acid infusion', 'reportingStatus': 'POSTED', 'populationDescription': 'Data Not collected given lack of correlation between symptoms and esophageal length.'}, {'type': 'SECONDARY', 'title': 'Number of Participants for Whom a Correlation Was Found Between Symptom Onset and Esophageal Shortening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non Cardiac Chest Pain Patients', 'description': 'Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.\n\nEsophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.'}, {'id': 'OG001', 'title': 'Healthy Controls', 'description': 'Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.\n\nEsophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '20 minutes', 'description': 'Esophageal shortening will be defined as the point during the 20 minute acid infusion at which the lower esophageal sphincter begins to migrate proximally. A 2 minute window following this time point will then be used to determine if patients symptoms increased by \\> 2 on a visual analogue pain scale between 0 - 10.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non Cardiac Chest Pain Patients', 'description': 'Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.\n\nEsophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.'}, {'id': 'FG001', 'title': 'Healthy Controls', 'description': 'Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.\n\nEsophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Non Cardiac Chest Pain Patients', 'description': 'Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.\n\nEsophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.'}, {'id': 'BG001', 'title': 'Healthy Controls', 'description': 'Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.\n\nEsophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '49.4', 'spread': '18.3', 'groupId': 'BG001'}, {'value': '50.9', 'spread': '14.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-23', 'studyFirstSubmitDate': '2013-04-16', 'resultsFirstSubmitDate': '2017-04-25', 'studyFirstSubmitQcDate': '2013-04-19', 'lastUpdatePostDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-25', 'studyFirstPostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Esophageal Length With Acid', 'timeFrame': 'Length at T= 20 minutes - Baseline (T=0)', 'description': 'Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion'}], 'secondaryOutcomes': [{'measure': 'Esophageal Length at Symptom Onset', 'timeFrame': '20 minutes', 'description': 'Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms'}, {'measure': 'Esophageal Length at Maximal Symptom Intensity', 'timeFrame': '20 minutes', 'description': 'Mean length of esophagus at peak patient reported symptom intensity with acid infusion'}, {'measure': 'Number of Participants for Whom a Correlation Was Found Between Symptom Onset and Esophageal Shortening', 'timeFrame': '20 minutes', 'description': 'Esophageal shortening will be defined as the point during the 20 minute acid infusion at which the lower esophageal sphincter begins to migrate proximally. A 2 minute window following this time point will then be used to determine if patients symptoms increased by \\> 2 on a visual analogue pain scale between 0 - 10.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non Cardiac Chest Pain'], 'conditions': ['Chest Pain Atypical Syndrome']}, 'descriptionModule': {'briefSummary': 'Non-cardiac chest pain (NCCP) is a common disorder whose pathophysiology is poorly understood. Some evidence suggests it may be related to sustained esophageal contractions (SECs) of longitudinal smooth muscle. The investigators have previously shown that acid is a trigger for SECs and results in shortening of the esophagus. In this study, the investigators plan to prospectively evaluate esophageal shortening responses to acid in a group of patients with NCCP compared to controls. The investigators will use high resolution esophageal manometry coupled with acid infusion to evaluate shortening. The investigators hypothesize that at least a subset of patients with NCCP will have an exaggerated esophageal shortening response to acid which correlates with symptom production. If our hypothesis proves true, this may lead to a future therapeutic target in the treatment of these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with non cardiac chest pain as diagnosed by cardiologist or other physician. Healthy Volunteers will include anyone in the Kingston area who fulfils Inclusion and Exclusion criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers:\n* free of esophageal symptoms\n* not on any acid suppressing medications\n* Non Cardiac Chest Pain Patients:\n* Angina like chest pain occuring at least once per month\n* Coronary artery disease ruled out by stress test or angiogram\n\nExclusion Criteria:\n\n* pre existing motility disorder of the esophagus\n* connective tissue disease\n* pregnancy\n* taking calcium channel blockers, Nitrates, Gabapentin, Narcotics, Tricyclic antidepressants, Anti seizure medications'}, 'identificationModule': {'nctId': 'NCT01839058', 'briefTitle': 'Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction?', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction?', 'orgStudyIdInfo': {'id': 'DMED-1559-13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non Cardiac Chest Pain Patients', 'description': 'Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.', 'interventionNames': ['Other: Esophageal Manometry']}, {'label': 'Healthy Controls', 'description': 'Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.', 'interventionNames': ['Other: Esophageal Manometry']}], 'interventions': [{'name': 'Esophageal Manometry', 'type': 'OTHER', 'description': 'Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.', 'armGroupLabels': ['Healthy Controls', 'Non Cardiac Chest Pain Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 5G2', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel Dieu Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'William Paterson, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Dr. William Paterson', 'investigatorAffiliation': "Queen's University"}}}}