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

CVD Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05716659
• Other study ID #: 202207146DIPB
• Status: Not yet recruiting
• Start date: May 30, 2023
• Est. completion date: August 31, 2032

Study information

• Verified date: December 2022
• Source: National Taiwan University Hospital
• Contact: Hsien-Li Kao, M.D., Ph.D.
• Phone: 02-23123456
• Email: hsienli_kao[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 750
• Est. completion date: August 31, 2032
• Est. primary completion date: July 31, 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• CVD
• Heart Failure
• Ischemic Stroke

Locations

Country	Name	City	State
Taiwan	NTUH	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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