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

ConditionCVD
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

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;

Disqualifiers

Under treatment for malignancy

Currently receiving immunosuppressants

Modified Rankin Scale (mRS) ≥2 prior to the stroke

Symptomatic HF in patients with acute ischemic stroke

Trial population

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. A. Patients with metabolic syndrome B. Patients with heart failure C. Patients with severe aortic valve stenosis who have been evaluated as suitable for transcatheter aortic valve replacement D. Acute ischemic stroke patients admitted to stroke intensive care unit

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

750 Participants
are grouped into 6 trial groups

6

Trial groups

See each trial group below.

Group A: Healthy subjects group
Group B: Metabolic syndrome group
Group C: Heart failure group
Group D: Heart failure with metabolic syndrome group
Group E: Severe aortic valve stenosis group
Group F: Ischemic stroke group

Trial outcomes

Primary outcomes

1

Composite cardiovascular outcome

Composite endpoint: Major adverse cardiac events (MACE): myocardial infarction, stroke, hospitalization for heart failure, or cardiovascular death)

Time frame
up to 10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: