Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-25 @ 2:59 PM
Study NCT ID:
NCT07158450
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Novel On-body Evaluation of Cardiac Health for Oncology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D066126', 'term': 'Cardiotoxicity'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between wearable-derived and transthoracic echocardiography-derived left ventricular ejection fraction estimates', 'timeFrame': 'From baseline through study completion (up to 6 months) at each paired assessment', 'description': 'The primary analysis will compute the correlation coefficient (r) between wearable-derived model estimates of LVEF and transthoracic echocardiography-derived LVEF in the Hold-Out Test Set. The prespecified performance target is r \\> 0.70.'}], 'secondaryOutcomes': [{'measure': 'Clinical accuracy of wearable-derived LVEF compared with echocardiography', 'timeFrame': 'From baseline through study completion (up to 6 months) at each paired assessment', 'description': 'Proportion of predictions within ±5 percentage points of TTE-derived LVEF in the Hold-Out Test Set. Error metrics will be calculated as Mean Absolute Error (MAE) between wearable-derived and TTE-derived LVEF. Differences across subgroups will be tested with ANOVA or Kruskal-Wallis as appropriate. Prespecified performance target: MAE ≤ 5 percentage points.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiotoxicity', 'Heart Failure']}, 'descriptionModule': {'briefSummary': "The goal of this study is to develop a wearable sensor system that can estimate left ventricular ejection fraction (LVEF), which is a measurement of the heart's function."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults (≥18 years) recruited from participating cardiology clinics. Participants are assigned to one of three cohorts by transthoracic echocardiography (TTE): Healthy (no known structural heart disease; LVEF ≥ 55%), Borderline/Possibly reduced LVEF (LVEF 40-54% or clinical concern for decline), and Reduced LVEF (LVEF \\< 40%). The population is intended to span the full spectrum of systolic function for model training and evaluation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing an echocardiogram irrespective of participation in this study\n* Willing and able to provide informed consent prior to any study-related activity\n\nExclusion Criteria:\n\n* Have a documented allergy to potential tissue contacting system materials\n* Have been diagnosed with one or more of the following cardiac diseases/conditions that distort cardiac activity:\n\n 1. Severe valve disease\n 2. Severe right ventricular dilation or dysfunction\n 3. Significant arrhythmias or conduction abnormalities\n 4. Active ischemia or myocardial infarction within the last 3 months\n* Have an active implantable cardiac device\n* Have any condition that would cause inaccurate TTE measurements'}, 'identificationModule': {'nctId': 'NCT07158450', 'acronym': 'NOECHO', 'briefTitle': 'Novel On-body Evaluation of Cardiac Health for Oncology', 'organization': {'class': 'INDUSTRY', 'fullName': 'Skribe Medical'}, 'officialTitle': 'Evaluation of Wearable Sensor-Based Estimation of Left Ventricular Ejection Fraction (LVEF) - Pilot Study', 'orgStudyIdInfo': {'id': 'SKR-LVEF-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy', 'description': 'No known or suspected cardiac disease'}, {'label': 'Borderline LVEF', 'description': 'Known conditions that may predispose to LV dysfunction, but no prior diagnosis of reduced left ventricular ejection fraction'}, {'label': 'Reduced LVEF', 'description': 'Known diagnosis of reduced left ventricular ejection fraction'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to proprietary device algorithms and consent restrictions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skribe Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Rochester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}