CVDNCT05716659
EEG/MECG/EMG Evaluating the Severity of Aortic Stenosis, Heart Failure and Ischemic Stroke Through an Artificial Intelligenceassisted System.
An observational study of CVD, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- CVD
- How many people
- 750 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 May 2023to 31 Aug 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
NTUH
Taipei
Hsien-Li Kao, M.D., Ph.D., 02-23123456 ext. 263671, hsienli_kao@yahoo.com
Chih-Fan Yeh, M.D., Ph.D., 02-23123456 ext. 262152, nicholas.yeh@gmail.com
About this study
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.
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.
- Conditions
- CVD
- Keywords
- heart failure, aortic stenosis, ischemic stroke
- Medical subject headings
- Heart Failure, Aortic Valve Stenosis, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite cardiovascular outcome
Composite endpoint: Major adverse cardiac events (MACE): myocardial infarction, stroke, hospitalization for heart failure, or cardiovascular death)
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start30 May 2023 (estimated)
- Primary completion31 Jul 2032 (estimated)
- Study completion31 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CVDStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsien-Li Kao, M.D., Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716659
- Sponsor's protocol ID
- 202207146DIPB
- Status last verified
- Dec 2022
- First submitted
- 29 Jan 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05716659
- Acronym / sponsor ID
- 202207146DIPB
- Conditions
- CVD
- Keywords
- heart failure, aortic stenosis, ischemic stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 30 May 2023 (estimated)
- Primary completion
- 31 Jul 2032 (estimated)
- Study completion
- 31 Aug 2032 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (8 listed)
- 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
- 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;
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hsien-Li Kao, M.D., Ph.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CVD, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsien-Li Kao, M.D., Ph.D. (02-23123456 ext. 263671, hsienli_kao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite cardiovascular outcome (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.