NCT05716659

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
77mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
May 2023Aug 2032

First Submitted

Initial submission to the registry

January 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2032

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2032

Last Updated

April 10, 2023

Status Verified

December 1, 2022

Enrollment Period

9.2 years

First QC Date

January 29, 2023

Last Update Submit

April 6, 2023

Conditions

CVD

Keywords

heart failureaortic stenosisischemic stroke

Outcome Measures

Primary Outcomes (1)

  • Composite cardiovascular outcome

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

    up to 10 years

Study Arms (6)

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.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NTUH

Taipei, Taiwan

Location

MeSH Terms

Conditions

Heart FailureAortic Valve StenosisIschemic Stroke

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAortic Valve DiseaseHeart Valve DiseasesVentricular Outflow ObstructionStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Hsien-Li Kao, M.D., Ph.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

02-23123456hsienli_kao@yahoo.com

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

CONTACT

02-23123456nicholas.yeh@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2023

First Posted

February 8, 2023

Study Start

May 30, 2023

Primary Completion (Estimated)

July 31, 2032

Study Completion (Estimated)

August 31, 2032

Last Updated

April 10, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)