EEG/MECG/EMG Evaluating the Severity of Aortic Stenosis,... | NCT05716659

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

NCT05716659

Sponsor

National Taiwan University Hospital

Status

Not yet recruiting

Last Update Posted

Apr 10, 2023Actual

Enrollment

750Estimated

Phase

Not provided

Conditions

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2023Estimated

Primary Completion Date

Jul 31, 2032Estimated

Completion Date

Aug 31, 2032Estimated

First Submitted Date

Jan 29, 2023

First Submission Date that Met QC Criteria

Jan 29, 2023

First Posted Date

Feb 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2023

Last Update Posted Date

Apr 10, 2023Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

750Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Hsien-Li Kao, M.D., Ph.D.	Contact	02-23123456	263671	hsienli_kao@yahoo.com
Chih-Fan Yeh, M.D., Ph.D.	Contact	02-23123456	262152	nicholas.yeh@gmail.com

ID	Term
D006333	Heart Failure
D001024	Aortic Valve Stenosis
D000083242	Ischemic Stroke

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases