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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05716659
Other study ID # 202207146DIPB
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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