Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-25 @ 2:20 PM
Study NCT ID:
NCT05716659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-10
First Post:
2023-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EEG/MECG/EMG Evaluating the Severity of Aortic Stenosis, Heart Failure and Ischemic Stroke Through an Artificial Intelligenceassisted System.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2032-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2023-01-29', 'studyFirstSubmitQcDate': '2023-01-29', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite cardiovascular outcome', 'timeFrame': 'up to 10 years', 'description': 'Composite endpoint: Major adverse cardiac events (MACE): myocardial infarction, stroke, hospitalization for heart failure, or cardiovascular death)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'aortic stenosis', 'ischemic stroke'], 'conditions': ['CVD']}, 'descriptionModule': {'briefSummary': 'The specific objectives and methods of this project are: (1) To test the feasibility and accuracy of integrating EEG, MECG and EMG for detecting the severity of diseases such as aortic stenosis, heart failure and ischemic stroke. (2) Improve the accuracy of this multi-channel brain-heart-muscle device by using an artificial intelligence auxiliary system. (3) Provide tailor-made interdisciplinary treatment strategies for patients with different disease states.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'In this project, seven hundred and fifty male or female patients with healthy subjects or meet the inclusion conditions of the following four diseases over 20 years of age will be enrolled.\n\nA. Patients with metabolic syndrome\n\nB. Patients with heart failure\n\nC. Patients with severe aortic valve stenosis who have been evaluated as suitable for transcatheter aortic valve replacement\n\nD. Acute ischemic stroke patients admitted to stroke intensive care unit', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Age≥20 year-old\n2. Healthy subjects or patients with A. Metabolic syndrome (MetS) ；B. HF with reduced ejection fractions (HFrEF, defined by left ventricular ejection fraction≤40%) and current or previous symptoms of HF；C. Severe aortic stenosis (defined aortic valve area \\< 1.0 cm2 or mean pressure gradient ≥ 40 mmHg), preparing to receive transcatheter aortic valve replacement ；D. Acute ischemic stroke and admitted to stroke intensive care unit (ICU), within 24 hours after onset\n\nThe criteria of MetS includes:\n\n1. Abdominal obesity: waist circumference (for Asians) ≥ 90 cm in men and ≥ 80 cm in women;\n2. Hyperglycemia: serum fasting glucose level ≥ 100 mg/dl, or receiving drug treatment for elevated blood sugar;\n3. Reduced high-density lipoprotein cholesterol (HDL-C): serum HDL-C \\< 40 mg/dl in men and \\< 50 mg/dl in women or on cholesterol drug treatment;\n4. Elevated triglycerides: serum triglyceride ≥ 150 mg/dl or on drug treatment of hypertriglyceridemia;\n5. Hypertension: systolic blood pressure ≥ 130 mmHg, diastolic blood pressure ≥ 85 mmHg, or on antihypertensive drug treatment.\n\nExclusion criteria:\n\n1. Under treatment for malignancy\n2. Currently receiving immunosuppressants\n3. Modified Rankin Scale (mRS) ≥2 prior to the stroke\n4. Symptomatic HF in patients with acute ischemic stroke\n5. Unable to perform neurocognitive function test\n6. Unable to evaluate the physical activity using questionnaire or 6-minute walk test\n7. Unable to cooperate with examinations using 3E combo machine.'}, 'identificationModule': {'nctId': 'NCT05716659', 'briefTitle': 'EEG/MECG/EMG Evaluating the Severity of Aortic Stenosis, Heart Failure and Ischemic Stroke Through an Artificial Intelligenceassisted System.', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Assessment of Brain-heart-muscle Axis Using EEG/MECG/EMG Combo Machine for Evaluating the Severity of Aortic Stenosis, Heart Failure and Ischemic Stroke Through an Artificial Intelligenceassisted System.', 'orgStudyIdInfo': {'id': '202207146DIPB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy subjects group', 'description': '150 healthy subjects'}, {'label': 'Metabolic syndrome group', 'description': '100 patients with clinical diagnosis of metabolic syndrome.'}, {'label': 'Heart failure group', 'description': '100 patients with clinical diagnosis of heart failure.'}, {'label': 'Heart failure with metabolic syndrome group', 'description': '100 patients with clinical diagnosis of heart failure with metabolic syndrome.'}, {'label': 'Severe aortic valve stenosis group', 'description': '100 patients with clinical diagnosis of severe aortic valve stenosis.'}, {'label': 'Ischemic stroke group', 'description': '200 patients with clinical diagnosis of ischemic stroke.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'contacts': [{'name': 'Hsien-Li Kao, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'hsienli_kao@yahoo.com', 'phone': '02-23123456', 'phoneExt': '263671'}, {'name': 'Chih-Fan Yeh, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'nicholas.yeh@gmail.com', 'phone': '02-23123456', 'phoneExt': '262152'}], 'facility': 'NTUH', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Hsien-Li Kao, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'hsienli_kao@yahoo.com', 'phone': '02-23123456', 'phoneExt': '263671'}, {'name': 'Chih-Fan Yeh, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'nicholas.yeh@gmail.com', 'phone': '02-23123456', 'phoneExt': '262152'}], 'overallOfficials': [{'name': 'Hsien-Li Kao, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}