EEG/MECG/EMG Evaluating the Severity of Aortic Stenosis, Heart Failure and Ischemic Stroke Through an Artificial Intelligenceassisted System.
NCT ID: NCT05716659
Last Updated: 2023-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
750 participants
OBSERVATIONAL
2023-05-30
2032-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Healthy subjects group
150 healthy subjects
No interventions assigned to this group
Metabolic syndrome group
100 patients with clinical diagnosis of metabolic syndrome.
No interventions assigned to this group
Heart failure group
100 patients with clinical diagnosis of heart failure.
No interventions assigned to this group
Heart failure with metabolic syndrome group
100 patients with clinical diagnosis of heart failure with metabolic syndrome.
No interventions assigned to this group
Severe aortic valve stenosis group
100 patients with clinical diagnosis of severe aortic valve stenosis.
No interventions assigned to this group
Ischemic stroke group
200 patients with clinical diagnosis of ischemic stroke.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. 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
The criteria of MetS includes:
1. Abdominal obesity: waist circumference (for Asians) ≥ 90 cm in men and ≥ 80 cm in women;
2. Hyperglycemia: serum fasting glucose level ≥ 100 mg/dl, or receiving drug treatment for elevated blood sugar;
3. 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;
4. Elevated triglycerides: serum triglyceride ≥ 150 mg/dl or on drug treatment of hypertriglyceridemia;
5. Hypertension: systolic blood pressure ≥ 130 mmHg, diastolic blood pressure ≥ 85 mmHg, or on antihypertensive drug treatment.
Exclusion Criteria
2. Currently receiving immunosuppressants
3. Modified Rankin Scale (mRS) ≥2 prior to the stroke
4. Symptomatic HF in patients with acute ischemic stroke
5. Unable to perform neurocognitive function test
6. Unable to evaluate the physical activity using questionnaire or 6-minute walk test
7. Unable to cooperate with examinations using 3E combo machine.
20 Years
ALL
Yes
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Hsien-Li Kao, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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NTUH
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202207146DIPB
Identifier Type: -
Identifier Source: org_study_id
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