Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT03064360
Status:
COMPLETED
Last Update Posted:
2020-07-21
First Post:
2017-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Prediction of Major Adverse Cardiovascular Events Using Remote Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-19', 'studyFirstSubmitDate': '2017-02-11', 'studyFirstSubmitQcDate': '2017-02-21', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Use of biomarkers (BNP and Troponin), PROs and PRIs, to predict a MACE event', 'timeFrame': '18 months', 'description': "The outcome of interest for this study is MACE, which investigators define as a composite outcome of events including: death (all cause), non-fatal MI, non-fatal stroke, or hospitalization for heart failure. Investigators will generate subject-specific monthly summary scores for the PRI and PRO metrics. Analysis of PRO's, PRIs, and biomarker surrogates will be completed using Pearson correlations. To adjust for known risk markers of MACE, investigators will run linear regressions with levels of biomarker surrogates as individual outcomes."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'Usual care may not identify subtle clinical changes that precede a major adverse cardiovascular event (MACE). Therefore investigators will explore the effectiveness of using biomarkers, patient reported outcomes (PROs), and patient reported informatics (PRIs) as predictors to a MACE event.', 'detailedDescription': 'Accurate assessment of cardiovascular risk is essential for clinical decision making in that the benefits, risks, and costs of alternative strategies must be weighed ahead of choosing the best treatment for individuals. Existing multivariable risk prediction models are vital components of current practice, and remain the logical standard to which new risk markers must be added and compared.7 The study described herein applies a practical framework for assessing the value of novel risk markers identified through patient reported outcomes (PROs), patient reported informatics (PRIs),8 and biomarkers in the forms of proteins and lipids. Though the purpose of the study is largely exploratory, it does take preliminary steps toward answering the question: "Do new PRO-, PRI-, and/or bio-markers add significant predictive information beyond that provided by established cardiac risk factors?" STUDY AIMS Aim 1: To measure cross-sectional correlations between PRIs, PROs, MACE biomarker candidates, and established MACE biomarker surrogates known to closely predict MACE itself (e.g. ultra-high sensitive troponin I \\[u-hsTnI\\], brain natriuretic peptide \\[BNP\\], and high sensitivity C-reactive protein \\[hsCRP\\], assay 1).\n\nHypothesis 1: PRI metrics, PRO measure scores, and Candidate Biomarkers will correlate with MACE biomarker surrogates.\n\nJustification: Usual care may not identify subtle clinical changes that precede MACE. In order to justify future efforts to employ remote monitoring at scale to predict MACE, we will first evaluate for evidence of basic, cross-sectional correlations between PRIs, PROs, and known MACE surrogate biomarkers.\n\nAim 2: To measure the longitudinal relationship between PRI metrics, PRO measure scores, Candidate Biomarkers, and changes in MACE surrogates.\n\nHypothesis: Changes in PRI metrics, PRO measure scores, and candidate biomarkers will predict changes in MACE biomarker surrogates.\n\nJustification: If changes in PRI metrics, PRO measure scores, and candidate biomarkers can predict longitudinal changes in MACE biomarker surrogates, then it will provide biological plausibility that remote surveillance may predict MACE itself; this would justify a larger trial of remote digital monitoring vs. usual care and suggest the concept has merit.\n\nExploratory Aim 2b: To assess improvement in risk prediction provided by risk markers identified in the above aims.\n\nHypothesis: Using PRI-, PRO-, and Bio- marker predictors in combination with established risk factors will provide incremental prognostic information compared to models using established risk factors alone. Additionally, we will perform in-depth proteomic and bioinformatics analysis using baseline samples to explore potential molecular mechanisms driving MACE.\n\nSpecific Aim 3: To estimate the cost-effectiveness and budget impact of remote monitoring for MACE. Hypothesis: The incremental cost of remote monitoring will be offset by downstream savings engendered by early and precise prediction of unexpected and costly MACE in stable moderate-risk IHD.\n\nJustification: Precision Medicine innovations must be cost-effective in order to be scaled across health systems and receive payer support. Using summary results from this study, we will create hypothesis-generating cost-effectiveness, cost-utility, and budget impact models to estimate the projected return on investment of remote monitoring. Importantly, these models are evaluative in nature and do not involve patient-level data - let alone identifiable information - of any sort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with history of Ischemic Heart Disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age 18 years or older\n* Patient with history of Ischemic Heart Disease\n* Access to iOS or Android device\n* Ambulatory\n\nExclusion Criteria:\n\n* Patient with planned revascularization or valve surgery\n* Patients with acute coronary syndrome\n* Patients with psychiatric or substance abuse'}, 'identificationModule': {'nctId': 'NCT03064360', 'briefTitle': 'Early Prediction of Major Adverse Cardiovascular Events Using Remote Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Early Prediction of Major Adverse Cardiovascular Event Surrogates Using Remote Monitoring With Biosensors, Biomarkers, and Patient-Reported Outcomes', 'orgStudyIdInfo': {'id': 'Pro00046458'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biomarker Testing, PROs, PRIs', 'description': 'Biomarker testing for cardiac biomarkers, B-type natriuretic peptide (BNP) and Troponin I (Tnl), symptom and quality of life questionnaires, and patient metrics (activity, sleep, heart rate, heart rate variability).', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Device: Patient Activity', 'Behavioral: Questionnaires']}], 'interventions': [{'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Blood drawn for biomarker analysis at baseline and study exit. Finger sticks at baseline, interim, and study exit.', 'armGroupLabels': ['Biomarker Testing, PROs, PRIs']}, {'name': 'Patient Activity', 'type': 'DEVICE', 'description': 'Continuous monitoring of Patient Reported Informatics (PRIs) at study entry to study completion.', 'armGroupLabels': ['Biomarker Testing, PROs, PRIs']}, {'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'description': 'Symptom and quality of life questionnaire at baseline, and every week following to study completion', 'armGroupLabels': ['Biomarker Testing, PROs, PRIs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Los Angeles', 'class': 'OTHER'}, {'name': 'HealthLoop', 'class': 'UNKNOWN'}, {'name': 'Neoteryx', 'class': 'UNKNOWN'}, {'name': 'California Initiative to Advance Precision Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Brennan Spiegel', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}