Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-22 @ 9:32 AM
Study NCT ID:
NCT02560168
Status:
COMPLETED
Last Update Posted:
2017-10-23
First Post:
2015-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Surface EKG Signals to Identify Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-19', 'studyFirstSubmitDate': '2015-09-23', 'studyFirstSubmitQcDate': '2015-09-23', 'lastUpdatePostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colorized waveform', 'timeFrame': 'Day 1', 'description': 'Spectrum analysis to represent levels and locations of cellular energy and automates the analysis into a simple indication of the level of myocardial abnormality if present.'}], 'secondaryOutcomes': [{'measure': 'Change in coronary plaque burden', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in coronary plaque burden at 3 months compared to baseline. Coronary plaque burden will be assessed by assigning a score (0 to 5) according to the SCCT guidelines (0, Normal: absence of plaque and no luminal stenosis; 1, Minimal: plaque with \\<25% stenosis; 2, Mild: 25% to 49% stenosis; 3, Moderate: 50%to 69% stenosis; 4, Severe: 70% to 99% stenosis; 5, Complete occlusion)'}, {'measure': 'Myocardial wall motion score index (WMSI)', 'timeFrame': 'Baseline', 'description': 'Myocardial wall motion score index (WMSI) will be obtained by dividing the left ventricle into 16 segments7. Each of the segments will be assigned a score that is based on myocardial thickening (1 for Normal or hyperkinetic, 2 for hypokinetic, 3 for akinetic, 4 for dyskinesis, 5 for aneurysmal dilatation). WMSI will be calculated as the sum of scores divided by the number of segments visualized.'}, {'measure': 'Serum electrolytes', 'timeFrame': '3 months', 'description': 'Serum electrolytes level to include sodium, potassium, calcium, and magnesium'}, {'measure': 'Serum creatinin level', 'timeFrame': '3 months'}, {'measure': 'Serum Brain natriuretic peptide (BNP) level', 'timeFrame': '3 months'}, {'measure': 'Serum cardiac enzymes', 'timeFrame': '3 months', 'description': 'Serum cardiac enzymes include creatinin kinase MB fraction (CK-MB)'}, {'measure': 'Serum high sensitivity C-reactive protein (hsCRP)', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Coronary artery disease', 'iECG', 'MyoVista', 'Heart Test Labs', 'Wavelet analysis', 'Surface electrocardiogram'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': '1. The MyoVista device is capable of detecting surface electrocardiogram signals and sensitive in detecting coronary artery disease compared to traditional computed tomography angiography (CTA)\n2. Electrophysiological signals at the cellular level of myocardium are related to specific patterns on the MyoVista device\n3. Changes in MyoVista device output and can indicative of future CAD outcomes and need for revascularization', 'detailedDescription': 'Background Myocardial ischemia is caused by myocardial oxygen supply and demand mismatch. Despite that coronary artery disease (CAD) is the major cause of myocardial ischemia, the symptoms may occur even in the absence of significant CAD. One of the mechanisms suggested for myocardial ischemia in these patients is microvascular ischemia (i.e. mismatch in microscopic vessels), affecting the myocardium (i.e. heart muscle) at the cellular level.\n\nA novel electrocardiographic recording method, the iECG is capable of capturing and amplifying signals from the cellular level that are much lower biologic signals than those processed by a traditional electrocardiogram (ECG). These recordings focus on early detection of myocardial abnormalities by non-linear analysis of electrical activity and physiological phenomenon. This novel assessment might be capable of detecting subclinical myocardial dysfunction in a variety of heart diseases.\n\nSpecific Aims\n\nAim#1: Study the feasibility of detection of CAD using iECG compared to computed tomographic coronary angiography (CTA).\n\nAim#2: Study the association between patterns of iECG and myocardial dysfunction in patients without CAD compared to echocardiography.\n\nAim#3: Study the effect of changes in iECG output on future outcomes of CAD and need for revascularization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sinus rhythms\n* Age\\>18 years\n* Both genders\n\nExclusion Criteria:\n\n* Acute coronary syndromes(ACS)\n* Contraindications to the administration of iodinated contrast\n* Pregnancy\n* Coronary artery bypass surgery (CABG)\n* History of cardiac valvular replacement\n* Implanted cardiac pacemaker\n* Chest deformities\n* Unwilling or unable to provide informed consent for study participation\n* Enrolled in another clinical study'}, 'identificationModule': {'nctId': 'NCT02560168', 'briefTitle': 'Analysis of Surface EKG Signals to Identify Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Multidimensional Wavelet Analysis of Surface Electrocardiogram for Identifying Subclinical Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'GCO 15-0726'}, 'secondaryIdInfos': [{'id': 'Heart Test Laboratories, Inc.', 'type': 'OTHER', 'domain': 'Icahn School of Medicine at Mount Sinai'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coronary artery disease', 'description': 'Patients scheduled for computed tomographic coronary angiography (CTA)', 'interventionNames': ['Device: MyoVista device', 'Device: Computed tomographic coronary angiography', 'Device: Transthoracic Echocardiography']}], 'interventions': [{'name': 'MyoVista device', 'type': 'DEVICE', 'otherNames': ['iECG'], 'description': 'MyoVista device is a standard EKG device with additional capabilities in detecting cellular level myocardial electrophysiological signals. The device involves placing leads on the chest, similar to a traditional EKG device', 'armGroupLabels': ['Coronary artery disease']}, {'name': 'Computed tomographic coronary angiography', 'type': 'DEVICE', 'otherNames': ['CTA'], 'description': 'Traditional method of detecting coronary artery disease. CTA will be performed using 64-detector row or higher scanners with electrocardiographic gating in accordance with the Society of Cardiovascular Computed Tomography (SCCT) guidelines. Approximately 80 to 100 ml of intravenous contrast, followed by 50 to 80 ml of saline, will be administered at a rate of 5 ml/s via a power injector through an antecubital vein (on forearm near the elbow).', 'armGroupLabels': ['Coronary artery disease']}, {'name': 'Transthoracic Echocardiography', 'type': 'DEVICE', 'otherNames': ['Echocardiogram'], 'armGroupLabels': ['Coronary artery disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Partho P Sengupta, MD, DM, FACC, FASE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart Test Laboratories, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine and Director of Cardiac Ultrasound Research and Core Lab', 'investigatorFullName': 'Partho Sengupta', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}