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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.

NCT04455568 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2020-07-23

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndrome
  • Percutaneous Transluminal Coronary Angioplasty

Interventions

DEVICE

use EKG Wisdom bracelet

Non-invasive Wearable Device (use EKG Wisdom bracelet)

Sponsors & Collaborators

  • Taipei Medical University WanFang Hospital

    collaborator OTHER

  • Taipei Medical University Hospital

    collaborator OTHER

  • Taipei Medical University

    collaborator OTHER

  • Lotung Poh-Ai Hospital

    collaborator OTHER

  • Taipei Medical University Shuang Ho Hospital

    lead OTHER

Principal Investigators

  • Ju-Chi Liu, MD · Chief, Internal of Medicine

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2022-07-20
Completion
2024-07-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04455568 on ClinicalTrials.gov