Establish a Telecare Model of Acute Coronary Syndrome Patient With Heart Stent Implantation by a Non-invasive Wearable Device and Artificial Intelligence Cloud to Reducing Medical Adverse Events.
NCT ID: NCT04455568
Last Updated: 2020-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2020-07-20
2024-07-20
Brief Summary
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This study is start on June 1 2020. We will enroll 400 patients who diagnosis of acute coronary syndrome and have been a heart stent surgery, and registry there medical history,routine examination and medication, ECG and heart, HRV and APG record at admission, pre-discharge and every routine return visit within I year after discharge.Patients will also wear ECG and PPG (Photoplethysmography) band ever day after discharge, and collected the longitutinal data .All subjects will be tracked the medical adverse events in 1 years after discharge, and compare the characteristic and prognosis value of between patients with and without events. Therefore, our purpose of this study is to drive an effective outcome prediction model by non-invasive device, and establish a telecare model of patient with heart stent implantation to reducing medical adverse events.
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Detailed Description
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Ask whether the patients who meet the exclusion criteria are willing to participate in the screening (Screening), if they are willing to join and sign the consent of the subject, and after the patient's condition is stable, conduct an electrocardiogram (V0) before discharge from the hospital. On day 7 (±2 weeks), day 84 (±4 weeks), 168 days (±4 weeks), 252 days (±4 weeks), 336 days (±8 weeks) during routine clinical referral (V1-V5) Both are done once. The results of these two tests and other basic information of the patient, including Demography, Vital Signs, High, Weight, Medication, and European and Taiwan Cardiology Association recommended routine test results of high-risk patients, including Blood Chemistry Panel, NT-proBNP, Echocardiography, Myocardial Perfusion Scan, etc., will record the information of the logged-in subjects on the paper case report form. The CRF (case report form) only displays the study number, and no subject is available. In addition to the examination of each return visit, the subjects also took the ECG bracelet home at the time of discharge (V0) and wore it every day. After the discharge, the ECG was measured every morning and evening, and their personal activity and sleep were collected. Relevant information. After the subject was discharged from the hospital, the subject tracked the date of all adverse events due to cardiovascular disease within one year, including: heart failure, restenosis due to blood vessel, and non-fatal myocardial infarction , To do blood vessel-related surgery again, and data on the occurrence of death.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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experimental group
Non-invasive Wearable Device, use ECG Wisdom bracelet
use EKG Wisdom bracelet
Non-invasive Wearable Device (use EKG Wisdom bracelet)
Interventions
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use EKG Wisdom bracelet
Non-invasive Wearable Device (use EKG Wisdom bracelet)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients performing general metal stent surgery
3. Diagnosis of Acute Coronary Syndrome
4. Willing to sign the consent form of the subject and cooperate with the return visit
5. Those who are admitted to the hospital and enter the general ward can receive the first ECG heart sound examination
Exclusion Criteria
2. Before the stent was installed, the same blood vessel had been used in patients with PCI (percutaneous coronary intervention) and CABG (Coronary artery bypass graft).
3. Those who cannot perform the first examination after being admitted to the hospital and entering the general ward
4. It is impossible to measure the group of ECG and heart sounds. For example, when using Pacemaker, the ECG showed ventricular tachycardia (VT) and Dextrocardia on admission.
5. Patients who are bedridden and have difficulty in cooperating with return visits
6. Any subject that the physician believes is at high risk for future uncooperative tracking
7. Direct participants in this program
20 Years
ALL
No
Sponsors
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Taipei Medical University WanFang Hospital
OTHER
Taipei Medical University Hospital
OTHER
Taipei Medical University
OTHER
Lotung Poh-Ai Hospital
OTHER
Taipei Medical University Shuang Ho Hospital
OTHER
Responsible Party
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Principal Investigators
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Ju-Chi Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Chief, Internal of Medicine
Central Contacts
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Other Identifiers
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N202004123
Identifier Type: -
Identifier Source: org_study_id
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