Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:02 PM
Study NCT ID:
NCT07398950
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2025-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2025-07-03', 'studyFirstSubmitQcDate': '2026-02-04', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance of the sequential screening approach', 'timeFrame': 'From enrollment through completion of PYP scan at baseline study visit', 'description': 'Measured by the positive predictive value (PPV) of the test for ATTR-CM, based on confirmatory imaging and clinical testing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transthyretin Amyloid Cardiomyopathy (ATTR-CM)', 'Artificial Intelligence Screening', 'AI-ECG', 'AI-Echo', 'Electrocardiogram', 'Technetium-99m Pyrophosphate (Tc99m-PYP) Scintigraphy', 'Machine Learning in Cardiology', 'Validation of AI Diagnostic Tools', 'Cardiomyopathy Screening', 'Early Detection of Cardiac Amyloidosis'], 'conditions': ['ATTR Amyloidosis With Cardiomyopathy', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'The TRACE-AI Diagnostic Study will evaluate the performance of artificial intelligence (AI) models applied to electrocardiograms (AI-ECG) and echocardiograms (AI-Echo) to identify transthyretin amyloid cardiomyopathy (ATTR-CM) in adults with heart failure. Model performance will be validated through comparison with technetium-99m pyrophosphate (PYP) imaging results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include participants from the YNHHS who were identified in Phase I of the TRACE-AI study. Eligible individuals must have a confirmed diagnosis of HFpEF or HFmrEF, 75 with a positive AI-based screening result from both AI-ECG and AI-Echo and 75 with a negative AI-based screen, and no prior diagnostic work-up for cardiac amyloidosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years or older with at least one of each component cardiovascular diagnosis testing (ECG and Echo) in the YNHHS.\n* Patients with a diagnosis of HFpEF or HFmrEF\n* Participant from Phase I TRACE-AI Study with AI-ECG and AI-Echo screen in the preceding 36 months\n\nExclusion Criteria:\n\n* Patients who have opted out of research studies\n* Patients with cardiac amyloid diagnostic test in the past 36 months\n* Patients with hypertrophic cardiomyopathy or end-stage renal disease\n* Pregnant women\n* Patients unable or unwilling to provide informed consent\n* Non-English speakers and cognitively impaired individuals who are unable to comprehend the consent and the on-screen instructions on the application, which are in English.'}, 'identificationModule': {'nctId': 'NCT07398950', 'acronym': 'TRACE-AI Yale', 'briefTitle': 'Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM): TRACE-AI Prospective Study', 'orgStudyIdInfo': {'id': '2000039677'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ATTR-CM AI-ECG and AI-Echo Model', 'type': 'DIAGNOSTIC_TEST', 'description': 'AI-based sequential screening approach for ATTR-CM'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'contacts': [{'name': 'Rohan Khera, MD, MS', 'role': 'CONTACT', 'email': 'rohan.khera@yale.edu', 'phone': '203-764-5585'}, {'name': 'Rohan Khera, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yale New Haven Health System', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Rohan Khera, MD, MS', 'role': 'CONTACT', 'email': 'rohan.khera@yale.edu', 'phone': '203-764-5885'}], 'overallOfficials': [{'name': 'Rohan Khera, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bridgebio Pharma, Inc', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}