Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05377320
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2022-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D066126', 'term': 'Cardiotoxicity'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-09', 'studyFirstSubmitDate': '2022-04-29', 'studyFirstSubmitQcDate': '2022-05-11', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication use', 'timeFrame': 'Week 0', 'description': 'The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.'}, {'measure': 'Medication use', 'timeFrame': 'Week 12', 'description': 'The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.'}, {'measure': 'Medication use', 'timeFrame': 'Week 24', 'description': 'The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.'}, {'measure': 'Imaging surveillance', 'timeFrame': 'Week 0', 'description': 'The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.'}, {'measure': 'Imaging surveillance', 'timeFrame': 'Week 12', 'description': 'The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.'}, {'measure': 'Imaging surveillance', 'timeFrame': 'Week 24', 'description': 'The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['clinical decision aid', 'cancer', 'cardiac dysfunction', 'cardio-oncology', 'artificial intelligence', 'machine learning', 'adverse events'], 'conditions': ['Heart Failure', 'Coronary Artery Disease', 'Peripheral Artery Disease', 'Ischemia', 'Hypertension', 'Diabetes Mellitus', 'Cardiomyopathies', 'Cardiotoxicity']}, 'referencesModule': {'references': [{'pmid': '36691060', 'type': 'BACKGROUND', 'citation': 'Brown SA, Chung BY, Doshi K, Hamid A, Pederson E, Maddula R, Hanna A, Choudhuri I, Sparapani R, Bagheri Mohamadi Pour M, Zhang J, Kothari AN, Collier P, Caraballo P, Noseworthy P, Arruda-Olson A; Cardio-Oncology Artificial Intelligence Informatics and Precision Equity (CAIPE) Research Team Investigators. Patient similarity and other artificial intelligence machine learning algorithms in clinical decision aid for shared decision-making in the Prevention of Cardiovascular Toxicity (PACT): a feasibility trial design. Cardiooncology. 2023 Jan 23;9(1):7. doi: 10.1186/s40959-022-00151-0.'}, {'pmid': '41378455', 'type': 'DERIVED', 'citation': 'Brown SA, Fang MZ, Sparapani R, Zhou Y, Osinski K, Taylor B, Yu D, Blessing J, Shah R, Collier P, BagheriMohamadiPour M, Zhang J, Kothari A, Echefu G, Rickards J, Otto C, Sanchez Z, Olson J, Arruda-Olson A, Cheng YC, Cheng F; Cardio-Oncology Artificial Intelligence Informatics and Precision Equity, and Patient Similarity Algorithms in the Prevention of Cardiovascular Toxicity Research Team Investigators. PrevCardioOncAI: Machine Learning Algorithms for Predicting Cardiovascular Disease in Cancer Survivors. J Am Heart Assoc. 2025 Dec 11:e030363. doi: 10.1161/JAHA.123.030363. Online ahead of print.'}, {'pmid': '37891699', 'type': 'DERIVED', 'citation': 'Brown SA, Hamid A, Pederson E, Bs AH, Maddula R, Goodman R, Lamberg M, Caraballo P, Noseworthy P, Lukan O, Echefu G, Berman G, Choudhuri I; Cardio-Oncology Artificial Intelligence Informatics & Precision Equity (CAIPE) and Patient Similarity Algorithms in the Prevention of Cardiovascular Toxicity (PACT) Research Team Investigators. Simplified rules-based tool to facilitate the application of up-to-date management recommendations in cardio-oncology. Cardiooncology. 2023 Oct 27;9(1):37. doi: 10.1186/s40959-023-00179-w.'}]}, 'descriptionModule': {'briefSummary': 'This is a single-center, double-arm, open-label, randomized feasibility study that will determine whether a novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists, will favorably impact appropriate medication use and cardiac imaging surveillance, and will improve clinician and patient decision-making, perception, and behavior towards cardioprotective medication usage and cardiovascular disease imaging utilization.', 'detailedDescription': 'For this feasibility study, the researchers will create the clinical decision aid and test the central hypothesis that this novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists and will favorably impact appropriate medication use and cardiac imaging surveillance. The hypothesis is supported by preliminary data suggesting that an initial and rudimentary version of the clinical aid increases appropriate medication use and imaging follow-up in cardio-oncology patients. Success will be determined by ≥85% of clinic visits using the clinical decision aid resulting in pursuit of medication use and cardiac imaging surveillance patterns commensurate with recommendations specific to cancer survivors, with overall rates the same or higher than the group without the clinical decision aid, as well as overall favorable patient and physician focus group comments and survey responses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer survivors at intermediate, high, or very high risk for developing cardiovascular disease will pursue a cardio-oncology visit.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients ≥18 years with a history of cancer.\n2. Have not previously visited a cardiologist to assess cardiovascular risk after cancer diagnosis.\n3. Clinically at intermediate, high, or very high risk for cardiovascular diseases determined based on imprecise clinical risk models, such as those used for cardiac dysfunction.\n4. Ability to understand a written informed consent form, and willing to sign it prior to study registration.\n\nExclusion Criteria:\n\n1. Patient \\<18 years.\n2. Without a personal history of cancer.\n3. Existing cardiomyopathy diagnosed after cancer diagnosis.\n4. Documented cognitive impairment.\n5. Patient or patient representative who is unable and unwilling to sign the informed consent form.'}, 'identificationModule': {'nctId': 'NCT05377320', 'briefTitle': 'PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study', 'orgStudyIdInfo': {'id': 'PRO00039290'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clinical Decision Aid Group', 'description': 'In this group, physicians will use standard care plus the clinical decision aid.', 'interventionNames': ['Other: Clinical Decision Aid']}, {'label': 'Control Group', 'description': 'In this group, physicians will use standard care only.', 'interventionNames': ['Other: Standard Care']}], 'interventions': [{'name': 'Clinical Decision Aid', 'type': 'OTHER', 'description': "The clinical decision aid tool will be used at the subject's first visit (Week 0), Week 12 and Week 24.", 'armGroupLabels': ['Clinical Decision Aid Group']}, {'name': 'Standard Care', 'type': 'OTHER', 'description': 'Cardiology clinic visits will take place at the subjects first visit (Week 0), Week 12 and Week 24.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'contacts': [{'name': 'Yee Chung Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Froedtert & the Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Yee Chung Cheng, MD', 'role': 'CONTACT', 'email': 'ycheng@mcw.edu', 'phone': '414-805-4600'}], 'overallOfficials': [{'name': 'Yee Chung Cheng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yee Chung Cheng', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}