EEG/MECG/EMG Evaluating the Severity of Aortic Stenosis, Heart Failure and Ischemic Stroke Through an Artificial Intelligenceassisted System.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: CVD. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Primary outcome measures
- Composite cardiovascular outcome [Time frame: up to 10 years]
Eligibility criteria
Inclusion criteria
- Age≥20 year-old
- 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:
- Abdominal obesity: waist circumference (for Asians) ≥ 90 cm in men and ≥ 80 cm in women;
- Hyperglycemia: serum fasting glucose level ≥ 100 mg/dl, or receiving drug treatment for elevated blood sugar;
- 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;
- Elevated triglycerides: serum triglyceride ≥ 150 mg/dl or on drug treatment of hypertriglyceridemia;
- Hypertension: systolic blood pressure ≥ 130 mmHg, diastolic blood pressure ≥ 85 mmHg, or on antihypertensive drug treatment.
Exclusion criteria
- Under treatment for malignancy
- Currently receiving immunosuppressants
- Modified Rankin Scale (mRS) ≥2 prior to the stroke
- Symptomatic HF in patients with acute ischemic stroke
- Unable to perform neurocognitive function test
- Unable to evaluate the physical activity using questionnaire or 6-minute walk test
- Unable to cooperate with examinations using 3E combo machine.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
Taiwan · 1 center
- NTUH — Taipei
Identifiers
NCT: NCT05716659 · 202207146DIPB