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.
1 other identifier
observational
400
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2020
CompletedFirst Posted
Study publicly available on registry
July 2, 2020
CompletedStudy Start
First participant enrolled
July 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2024
CompletedJuly 23, 2020
June 1, 2020
2 years
June 28, 2020
July 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
death
death
Within a year
Restenosis
Restenosis
Within a year
heart failure
heart failure
Within a year
Secondary Outcomes (7)
heart disease re-hospitalization
Within a year
Stroke re-hospitalization
Within a year
Arrhythmia re-hospitalization
Within a year
Physician adjusts medicine
Within a year
Physician arranges examination early
Within a year
- +2 more secondary outcomes
Study Arms (1)
experimental group
Non-invasive Wearable Device, use ECG Wisdom bracelet
Interventions
Non-invasive Wearable Device (use EKG Wisdom bracelet)
Eligibility Criteria
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).
You may qualify if:
- ≥ 20-year-old
- Patients performing general metal stent surgery
- Diagnosis of Acute Coronary Syndrome
- Willing to sign the consent form of the subject and cooperate with the return visit
- Those who are admitted to the hospital and enter the general ward can receive the first ECG heart sound examination
You may not qualify if:
- \<20-year-old
- 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).
- Those who cannot perform the first examination after being admitted to the hospital and entering the general ward
- 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.
- Patients who are bedridden and have difficulty in cooperating with return visits
- Any subject that the physician believes is at high risk for future uncooperative tracking
- Direct participants in this program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taipei Medical University Shuang Ho Hospitallead
- Taipei Medical University WanFang Hospitalcollaborator
- Taipei Medical University Hospitalcollaborator
- Taipei Medical Universitycollaborator
- Lotung Poh-Ai Hospitalcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ju-Chi Liu, MD
Chief, Internal of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2020
First Posted
July 2, 2020
Study Start
July 20, 2020
Primary Completion
July 20, 2022
Study Completion
July 20, 2024
Last Updated
July 23, 2020
Record last verified: 2020-06