NCT05716659Not yet recruiting
EEG/MECG/EMG Evaluating the Severity of Aortic Stenosis, Heart Failure and Ischemic Stroke Through an Artificial Intelligenceassisted System.
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.
Source: ClinicalTrials.gov · Last updated 10 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 750 (estimated)
- First submitted
- 29 Jan 2023
- Start date
- 30 May 2023
- Primary completion date
- 31 Jul 2032
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Heart failure, Stroke
- NCT number
- NCT05716659
What you commit to
- Study type: Observational
- Planned participants: 750
- From 30 May 2023 to the primary completion date, 31 Jul 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving immunosuppressants
- Modified Rankin Scale (mRS) ≥2 prior to the stroke
Other illness
- Under treatment for malignancy
- Symptomatic HF in patients with acute ischemic stroke
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 20 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NTUH Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.