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NCT Number: NCT05716659

EEG/MECG/EMG 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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

The criteria of MetS includes:

  • 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;
  • 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;
  • Elevated triglycerides: serum triglyceride ≥ 150 mg/dl or on drug treatment of hypertriglyceridemia;
  • Hypertension: systolic blood pressure ≥ 130 mmHg, diastolic blood pressure ≥ 85 mmHg, or on antihypertensive drug treatment.

Exclusion criteria

  • Under treatment for malignancy
  • Currently receiving immunosuppressants
  • Modified Rankin Scale (mRS) ≥2 prior to the stroke
  • Symptomatic HF in patients with acute ischemic stroke
  • Unable to perform neurocognitive function test
  • Unable to evaluate the physical activity using questionnaire or 6-minute walk test
  • Unable to cooperate with examinations using 3E combo machine.

Treatment and study plan

Primary outcomes

  1. Composite cardiovascular outcome

    Time frame: up to 10 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chih-Fan Yeh, M.D., Ph.D.

CONTACT

[email protected]

02-23123456 ext. 262152

Hsien-Li Kao, M.D., Ph.D.

CONTACT

[email protected]

02-23123456 ext. 263671

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2032
Study completion
2032
First posted
Feb 8, 2023
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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