EEG/MECG/EMG Evaluating the Severity of Aortic Stenosis, Heart Failure and Ischemic Stroke Through an Artificial Intelligenceassisted System.

National Taiwan University

Status: Not yet enrolling

Conditions: CVD

Study type: Observational

Funder types: Other

Identifiers

NCT05716659

202207146DIPB

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Age≥20 year-old
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:

1. Under treatment for malignancy
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.

Trial design

750 participants in 6 patient groups

Healthy subjects group

Description:

150 healthy subjects

Metabolic syndrome group

Description:

100 patients with clinical diagnosis of metabolic syndrome.

Heart failure group

Description:

100 patients with clinical diagnosis of heart failure.

Heart failure with metabolic syndrome group

Description:

100 patients with clinical diagnosis of heart failure with metabolic syndrome.

Severe aortic valve stenosis group

Description:

100 patients with clinical diagnosis of severe aortic valve stenosis.

Ischemic stroke group

Description:

200 patients with clinical diagnosis of ischemic stroke.