Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-31 @ 2:28 PM
Study NCT ID:
NCT01564628
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2012-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Data Acquisition for Optimization of Coronary Artery Disease (CAD) Algorithm
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dkcbc@acarix.com', 'phone': '+45 29724411', 'title': 'Claus Christensen', 'organization': 'Acarix A/S'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Study Participants', 'description': 'Population from 2 sites, sequential design with all patients undergoing CADScor1 intervention followed by the diagnostic testing the patients were referred to (procedure done according to standard of care and not part of study; computerized tomographic angiography (CTA) and, if relevant, coronary angiography (CAG) at Site 1 and CAG at site 2).', 'otherNumAtRisk': 298, 'deathsNumAtRisk': 298, 'otherNumAffected': 0, 'seriousNumAtRisk': 298, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'Population from 2 sites, sequential design with all patients undergoing CADScor1 intervention followed by the diagnostic testing the patients were referred to (procedure done according to standard of care and not part of study; computerized tomographic angiography (CTA) and, if relevant, coronary angiography (CAG) at Site 1 and CAG at site 2).'}], 'classes': [{'categories': [{'measurements': [{'value': '73.4', 'groupId': 'OG000', 'lowerLimit': '66.2', 'upperLimit': '80.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Heart sound recordings measured on testday (25 minutes study period)', 'description': 'Cardiac noise marker (CAD-score) ability to separate CAD from non-CAD patients is estimated as the area under the receiver operating characteristic curve.\n\nThe area under the receiver operating characteristic curve is plottet as sensitivity versus 1-specificity as a function of different CAD-score cut-off values.\n\nThe area under the receiver operating characteristic curve is on a scale from 0-100%, the higher value means a better separation of CAD from non-CAD patients.\n\nCAD and non-CAD patients are defined by the CTA and CAG evaluations.', 'unitOfMeasure': 'percentage of 100', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Site 1A Population - CAD-score/CTA/CAG', 'description': 'Site 1A study population. Subject to CAD-score, CTA and, if relevant, CAG investigation.'}, {'id': 'FG001', 'title': 'Site 2 Population - CAD-score/CAG', 'description': 'Site 2 study population. Subject to CAD-score and CAG investigation'}, {'id': 'FG002', 'title': 'Site 1B Population - CAD-score/CTA/CAG', 'description': 'Site 1B study population. Subject to CAD-score, CTA and, if relevant, CAG investigation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Population from 2 sites, sequential design with all patients undergoing CADScor1 intervention followed by the diagnostic testing the patients were referred to (procedure done according to standard of care and not part of study; computerized tomographic angiography (CTA) and, if relevant, coronary angiography (CAG) at Site 1 and CAG at site 2).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '10.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '138', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '160', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'categories': [{'measurements': [{'value': '298', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'PP population.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-15', 'studyFirstSubmitDate': '2012-03-21', 'resultsFirstSubmitDate': '2019-03-14', 'studyFirstSubmitQcDate': '2012-03-26', 'lastUpdatePostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-15', 'studyFirstPostDateStruct': {'date': '2012-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients.', 'timeFrame': 'Heart sound recordings measured on testday (25 minutes study period)', 'description': 'Cardiac noise marker (CAD-score) ability to separate CAD from non-CAD patients is estimated as the area under the receiver operating characteristic curve.\n\nThe area under the receiver operating characteristic curve is plottet as sensitivity versus 1-specificity as a function of different CAD-score cut-off values.\n\nThe area under the receiver operating characteristic curve is on a scale from 0-100%, the higher value means a better separation of CAD from non-CAD patients.\n\nCAD and non-CAD patients are defined by the CTA and CAG evaluations.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CAD'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).', 'detailedDescription': 'Acoustic information from the heart is obtained from patients referred to examination for Coronary Artery Disease. The acoustic signals are evaluated as indicators for CAD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred to examination for Coronary Artery Disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years old\n* Referred to diagnostically Ca-CT, CT scan and/or CAG examination due to suspicion of coronary artery disease\n* Subjects condition must be stable and the subject must not be referred due to suspicion of acute coronary syndrome\n* Subject is willing to adhere to the study procedure\n* Has signed the informed consent form and authorization to registration and publication of health information\n\nExclusion Criteria:\n\n* Has acute coronary syndrome or stroke\n* Arterial fibrillation\n* Known severe arrhythmia or resting heart rate above 85 bpm\n* Known diastolic murmurs due to heart valve disease\n* Has had a previous by-pass operation, open chest surgery, donor heart or mechanical heart\n* Reduced ejection fraction \\< 50%\n* Inability to understand or adhere to instructions for acoustic Data-acquisition (i.e. subject not able to hold breath due to KOL or asthma)\n* Inability to perform CT-angio and/or subsequent CAG\n* In active treatment for any cancer\n* In active treatment for immunosuppression after transplantation\n* Established or pursuing pregnancy or breast feeding\n* Has damaged skin on the spot where the patch is placed during the recordings.'}, 'identificationModule': {'nctId': 'NCT01564628', 'briefTitle': 'Data Acquisition for Optimization of Coronary Artery Disease (CAD) Algorithm', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acarix'}, 'officialTitle': 'Data Acquisition for Optimization of Coronary Artery Disease Algorithm', 'orgStudyIdInfo': {'id': 'AC003-SH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All study participants', 'description': 'Population from 2 sites, sequential design with all patients undergoing CADScor1 intervention followed by the diagnostic testing the patients were referred to (procedure done according to standard of care and not part of study; computerized tomographic angiography (CTA) and, if relevant, coronary angiography (CAG) at Site 1 and CAG at site 2).', 'interventionNames': ['Device: CADScor1']}], 'interventions': [{'name': 'CADScor1', 'type': 'DEVICE', 'description': 'Acoustic recording', 'armGroupLabels': ['All study participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'University Hospital of Aarhus, Skejby', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}], 'overallOfficials': [{'name': 'Morten Bøttcher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Aarhus, Skejby'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acarix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}