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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: CVD

• Study Type: Observational
• Enrollment (Anticipated): 750

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • NTUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
Healthy subjects group; 150 healthy subjects
Metabolic syndrome group; 100 patients with clinical diagnosis of metabolic syndrome.
Heart failure group; 100 patients with clinical diagnosis of heart failure.
Heart failure with metabolic syndrome group; 100 patients with clinical diagnosis of heart failure with metabolic syndrome.
Severe aortic valve stenosis group; 100 patients with clinical diagnosis of severe aortic valve stenosis.
Ischemic stroke group; 200 patients with clinical diagnosis of ischemic stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite cardiovascular outcome	Composite endpoint: Major adverse cardiac events (MACE): myocardial infarction, stroke, hospitalization for heart failure, or cardiovascular death)	up to 10 years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 30, 2023
• Primary Completion (Anticipated): July 31, 2032
• Study Completion (Anticipated): August 31, 2032

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: January 29, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: heart failure; ischemic stroke; aortic stenosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Stroke; Heart Failure; Ischemic Stroke; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 202207146DIPB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No