Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-27 @ 10:01 AM
Study NCT ID:
NCT02069405
Status:
COMPLETED
Last Update Posted:
2014-12-08
First Post:
2013-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relaxation Music to Lower Heart Rate Prior to Cardiac CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-05', 'studyFirstSubmitDate': '2013-12-11', 'studyFirstSubmitQcDate': '2014-02-19', 'lastUpdatePostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Heart Rate', 'timeFrame': 'Same day as CT scan', 'description': 'Unit of measure - beats per minute'}], 'secondaryOutcomes': [{'measure': 'Radiation Dose', 'timeFrame': 'Same day as CT scan', 'description': 'Unit of measure - millisieverts'}, {'measure': 'Image Quality', 'timeFrame': 'Same day as CT scan', 'description': 'Measurement tool - Likert Scale. Review of images by two highly experienced cardiac radiologists'}, {'measure': 'IV metoprolol dose', 'timeFrame': 'Same day as CT scan', 'description': 'Unit of measurement - milligrams'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'Same day as CT scan', 'description': 'Measurement tool - Modified state-trait anxiety inventory (STAI) questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease and Cardiac Anatomy', 'Patients Undergoing Coronary CT Angiogram', 'Patients Undergoing CT Pulmonary Vein Angiogram', 'Patients Undergoing CT Calcium Score']}, 'descriptionModule': {'briefSummary': 'To acquire low radiation dose and good quality cardiac CT images requires scanning at low heart rates which is usually done with beta-blockers. However, in some patients beta-blockers have little effect. This is thought to be due to a different mechanism of action which continues to maintain the heart rate despite administration of beta-blockers. This study aims to look at the effect of music or relaxation tracks to reduce patient heart rate as anxiety is thought to play a role in maintaining high heart rates. This study will randomise patients into a normal standard of care group compared to a normal standard of care group with music/ relaxation track and compare heart rate, radiation dose, image quality, amount of beta-blocker used and patient experience via a State-Trait Anxiety Inventory (STAI) questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 years and above\n* All patients coming in for non-contrast enhanced calcium score CT, pulmonary vein angiogram, or coronary CT Angiogram\n\nExclusion Criteria:\n\n* Deaf\n* CT for Transcatheter aortic valve implantation (TAVI) or congenital heart disease patients\n* Poor english literacy\n* Pacemaker\n* Post CABG\n* Post heart transplant'}, 'identificationModule': {'nctId': 'NCT02069405', 'briefTitle': 'Relaxation Music to Lower Heart Rate Prior to Cardiac CT', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Relaxation Music to Lower Heart Rate Prior to Cardiac CT', 'orgStudyIdInfo': {'id': '13-6798-AE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music Group plus normal standard of care', 'description': 'Patients will listen to music prior and during the scan', 'interventionNames': ['Other: Relaxation Music']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group - Normal standard of care'}], 'interventions': [{'name': 'Relaxation Music', 'type': 'OTHER', 'armGroupLabels': ['Music Group plus normal standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'm5g2c4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network, Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Elsie Nguyen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Joint Department of Medical Imaging'}, {'name': 'Ming-Yen Ng, BMBS', 'role': 'STUDY_CHAIR', 'affiliation': 'University Health Network, Joint Department of Medical Imaging'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}