Clinical trial NCT05716659: EEG/MECG/EMG Evaluating the Severity of Aortic Stenosis, Heart Failure and Ischemic Stroke Through an Artificial Intelligenceassisted System.
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.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: CVD
Keywords: heart failure
aortic stenosis
ischemic stroke
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 750
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study 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

Brief summary: 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: 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.

Primary outcomes:
measure: Composite cardiovascular outcome
timeFrame: up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH
Study officials:
affiliation: National Taiwan University Hospital
name: Hsien-Li Kao, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: