Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 9:29 PM
Study NCT ID:
NCT07351656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2026-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Of Heart Disease Using AI-Enabled Electrocardiography And Focused Cardiac Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 19300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-10', 'studyFirstSubmitDate': '2026-01-10', 'studyFirstSubmitQcDate': '2026-01-10', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with positive AI-ECG findings confirmed by echocardiography (Adolescents and young adults)', 'timeFrame': 'Baseline', 'description': 'The percentage will be calculated as the number of participants whose AI-ECG results indicate a positive finding and are subsequently confirmed by echocardiography, divided by the total number of participants assessed, multiplied by 100.'}, {'measure': 'Number of patients with positive AI-ECG detection for left-right sided SHD (Community Dwelling Adults)', 'timeFrame': 'Baseline', 'description': 'Number of patients with positive AI-ECG detection for left-right sided SHD, defined as any of the following: LVEF \\<50%, \\>moderate right ventricular systolic dysfunction, \\>moderate aortic, mitral, or tricuspid valve regurgitation or stenosis, pulmonary hypertension (right ventricular systolic pressure \\> 50 mmHg), or elevated left-sided filling pressure.'}, {'measure': 'Number of times the AI-ECG provides a correct diagnosis of clinically significant cardiac disease (Pregnant women)', 'timeFrame': 'Baseline', 'description': 'Diagnostic performance of the AI-ECG will be determined by the accurate diagnosis of cardiomyopathy (left ventricular ejection fraction \\[LVEF\\] ≤50% or 10% or more decline in LVEF) or clinically significant structural heart disease (SHD; ≥ moderate right ventricular systolic dysfunction, ≥ moderate aortic, mitral, or tricuspid valve regurgitation or stenosis, pulmonary hypertension \\[right ventricular systolic pressure \\> 50 mmHg\\], or myocardial disease such as hypertrophic cardiomyopathy) in pregnant patients and those up to 6 weeks postpartum compared to standard of care.'}], 'secondaryOutcomes': [{'measure': 'Number of false positive AI-ECG Results (Adolescents and young adults)', 'timeFrame': 'Baseline', 'description': 'Number of false positive AI-ECG results will be determined by the number of positive AI-ECG results proven false from an echocardiography'}, {'measure': 'Number of positive AI-ECG results for hypertrophic cardiomyopathy (HCM) (Adolescents and young adults)', 'timeFrame': 'Baseline', 'description': 'The number of positive AI-ECG results for HCM will be based on how many patient ECGs indicate a possible diagnosis of HCM'}, {'measure': 'Number of positive AI-ECG results for congenital heart defect (CHD) (Adolescents and young adults)', 'timeFrame': 'Baseline', 'description': 'The number of positive AI-ECG results for CHD will be based on how many patient ECGs indicate a possible diagnosis of CHD'}, {'measure': 'Proportion of patients by age group to receive a diagnosis (Community Dwelling Adults)', 'timeFrame': 'Baseline', 'description': 'Proportion of patients by age group (30-39, 40-49, 50-65, 65-74, and 75 years and older) to receive a diagnosis from ultrasound that is confirmed by a comprehensive diagnostic work up.'}, {'measure': 'Proportion of total patients to receive a diagnosis based on screening with 6 lead ECG (Community Dwelling Adults)', 'timeFrame': 'Baseline', 'description': 'Proportion of total patients to receive a diagnosis based on screening with 6 lead ECG will be determined by the number of patients to have a correct diagnosis using the 6 lead ECG confirmed by echocardiogram compared to the total number of patients.'}, {'measure': 'Proportion of total patients to receive a diagnosis based on screening with 12 lead ECG (Community Dwelling Adults)', 'timeFrame': 'Baseline', 'description': 'Proportion of total patients to receive a diagnosis based on screening with 12 lead ECG will be determined by the number of patients to have a correct diagnosis using the 12 lead ECG confirmed by echocardiogram compared to the total number of patients.'}, {'measure': 'Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG with adjunctive FoCUS (Community Dwelling Adults)', 'timeFrame': 'Baseline', 'description': 'Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG with adjunctive FoCUS will be determined by the number of patients to have a correct diagnosis using the 12 lead ECG with adjunctive FoCUS confirmed by standard of care echocardiogram compared to the total number of patients.'}, {'measure': 'Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG without adjunctive FoCUS (Community Dwelling Adults)', 'timeFrame': 'Baseline', 'description': 'Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG without adjunctive FoCUS will be determined by the number of patients to have a correct diagnosis using the 12 lead ECG without adjunctive FoCUS confirmed by standard of care echocardiogram compared to the total number of patients.'}, {'measure': 'Number of non-cardiac adverse events (Pregnant Women)', 'timeFrame': 'Baseline', 'description': 'Number of non-cardiac adverse events can include hypertensive disorders of pregnancy (gestational hypertension, pre-eclampsia, eclampsia), preterm delivery, gestational diabetes, small for gestational age delivery, placental abruption, and pregnancy loss.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Disease']}, 'descriptionModule': {'briefSummary': 'A study to evaluate feasibility, diagnostic yield, accuracy, and actionable thresholds of POC, immediate-feedback AI-ECG + AI FoCUS screening for cardiac disease in well described community populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Adolescents and young adults:\n\nInclusion Criteria:\n\n* Enrollment in a high-school, college or a resident in MN during the study period\n* Age 15-29 years\n* Informed consent (and assent for minors)\n\nExclusion Criteria:\n\n* Presence of a pacemaker or defibrillator\n* Inability to obtain a quality ECG tracing\n\nCommunity dwelling adults:\n\nInclusion Criteria:\n\n• Adult patients (\\>30 years of age, with pre-specified subgroups 30-64 and 65+))\n\nExclusion Criteria:\n\n• Inability to provide informed consent to participate in the study\n\nPregnant women:\n\nInclusion Criteria:\n\n* Adult female aged 18 to 49 years\n* Pregnant at the time of enrollment\n* Receiving obstetric care at identified study site(s)\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n• Inability to provide consent'}, 'identificationModule': {'nctId': 'NCT07351656', 'briefTitle': 'A Study Of Heart Disease Using AI-Enabled Electrocardiography And Focused Cardiac Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Screening for Heart Disease Using AI-Enabled Electrocardiography and Focused Cardiac Ultrasound: the AI CVD Screen Study.', 'orgStudyIdInfo': {'id': '25-012252'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Community dwelling adults', 'interventionNames': ['Diagnostic Test: Focused Cardiac Ultrasound', 'Diagnostic Test: 6-Lead AI-ECG', 'Diagnostic Test: 12-Lead AI-ECG']}, {'type': 'EXPERIMENTAL', 'label': 'Pregnant women', 'interventionNames': ['Diagnostic Test: Focused Cardiac Ultrasound', 'Diagnostic Test: 6-Lead AI-ECG', 'Diagnostic Test: 12-Lead AI-ECG']}, {'type': 'EXPERIMENTAL', 'label': 'Adolescents and young adults', 'interventionNames': ['Diagnostic Test: Focused Cardiac Ultrasound', 'Diagnostic Test: 6-Lead AI-ECG', 'Diagnostic Test: 12-Lead AI-ECG']}], 'interventions': [{'name': 'Focused Cardiac Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Focused cardiac ultrasound will utilize sonography to evaluate specific cardiac conditions, such as ventricular function, pericardial effusion, and valvular abnormalities.', 'armGroupLabels': ['Adolescents and young adults', 'Community dwelling adults', 'Pregnant women']}, {'name': '6-Lead AI-ECG', 'type': 'DIAGNOSTIC_TEST', 'description': "A 6-lead ECG uses six electrodes placed on the chest and limbs to record the heart's electrical activity from multiple perspectives.", 'armGroupLabels': ['Adolescents and young adults', 'Community dwelling adults', 'Pregnant women']}, {'name': '12-Lead AI-ECG', 'type': 'DIAGNOSTIC_TEST', 'description': "A standard 12-lead ECG consists of 12 leads: 6 limb leads and 6 chest (precordial) leads. These leads record the heart's electrical activity from different angles to provide a comprehensive assessment of cardiac function.", 'armGroupLabels': ['Adolescents and young adults', 'Community dwelling adults', 'Pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'contacts': [{'name': 'Amanda Priebe', 'role': 'CONTACT', 'email': 'Priebe.Amanda@mayo.edu', 'phone': '507-422-6932'}, {'name': 'Paul Friedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Amanda Priebe', 'role': 'CONTACT', 'email': 'Priebe.Amanda@mayo.edu', 'phone': '507-422-6932'}], 'overallOfficials': [{'name': 'Paul Friedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Paul A. Friedman', 'investigatorAffiliation': 'Mayo Clinic'}}}}