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.

Establish a Telecare Model of Acute Coronary Syndrome Patient With Heart Stent Implantation by a Non-invasive Wearable Device and Artificial Intelligence Cloud System to Heart Failure Monitoring and Reducing Medical Adverse Events.

Heart disease is still one of the world's most important health problems, and it ranks second among the top ten causes of death among Taiwan. The main cause of death is acute coronary syndrome, and vascular stent placement is the main treatment method for acute coronary syndrome. The probability of restenosis in patients within half a year after a general stent is as high as 25% to 40%. Re-hospitalization and surgery is a big burden on patients and the country's medical costs. However, a set of convenient and accurate clinical tools to determine the prognosis of patients has not yet been developed. Miniaturized wearable devices have been the mainstream trend in medical development in recent years. ECG and heart sound analysis technology are an easy to used medical device for automatically calculating the parameters including EMAT (electromechanical activation time), S4, S4, SDI (Systolic dyssynchrony index). ECG and heart sound could evaluate the heart function, and has the potential to be an effective tools for prognosis and treatment guidelines. Heart rate variability (HRV) and Accelerationplethysmogram (APG) is also proved the predictive effect the outcome of patients.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Coronary Syndrome; Percutaneous Transluminal Coronary Angioplasty
• Intervention / Treatment: Device: use EKG Wisdom bracelet

Detailed Description

This study is open, prospective study, multi-center, randomized controlled trial, unobtrusive research. 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 random allocation 200 experimental group (Non-invasive Wearable Device) and 200 control group (routine medical).

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We will enroll 400 patients who diagnosis of acute coronary syndrome and have been a heart stent surgery. And random allocation 200 experimental group (Non-invasive Wearable Device) and 200 control group (routine medical).

Description

Inclusion Criteria:

1. ≥ 20-year-old
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:

1. <20-year-old
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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
experimental group; Non-invasive Wearable Device, use ECG Wisdom bracelet	Device: use EKG Wisdom bracelet; Non-invasive Wearable Device (use EKG Wisdom bracelet); Other Names: control group (routine medical)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
death	death	Within a year
Restenosis	Restenosis	Within a year
heart failure	heart failure	Within a year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart disease re-hospitalization	heart disease re-hospitalization	Within a year
Stroke re-hospitalization	Stroke re-hospitalization	Within a year
Arrhythmia re-hospitalization	Arrhythmia re-hospitalization	Within a year
Physician adjusts medicine	Physician adjusts medicine	Within a year
Physician arranges examination early	Physician arranges examination early	Within a year
Medical Compliance	Judged by the physician, when the patient returns to the consultation, the patient is asked about the compliance with the drug in the past, divided into presence and absence	Within a year
Medical Costs	The sum of all medical and health insurance expenses of the patient in the past year	Within a year

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Collaborators: Taipei Medical University; Taipei Medical University Hospital; Taipei Medical University WanFang Hospital; Lotung Poh-Ai Hospital
• Investigators: Principal Investigator: Ju-Chi Liu, MD, Chief, Internal of Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 20, 2020
• Primary Completion (ANTICIPATED): July 20, 2022
• Study Completion (ANTICIPATED): July 20, 2024

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: June 28, 2020
• First Posted (ACTUAL): July 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Acute Coronary Syndrome; Non-invasive Wearable Device; Telecare Model of Patient,
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: N202004123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No