Cloud-based ECG Monitoring and Healthcare Model Building on the Population With Coronary Artery Revascularization
1 other identifier
observational
700
0 countries
N/A
Brief Summary
Percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) are the golden treatments for stable coronary artery disease (CAD) combined with heart failure (HF). The goal of treating HF patients is to prevent repeated hospitalizations and improve peri-operative survival; clinically, although routines including beta-receptor inhibitors, angiotensin-converting enzyme (ACE) inhibitors, and mineralocorticoids have been shown beneficial for the prognosis, for patients with severely low left ventricular ejection rate, hypotension, and pulmonary disease, the introduction of these drugs in the early postoperative period should still be cautious and may need to be adjusted with related cardiovascular function parameters. Patients with low cardiac output syndrome, ventricular arrhythmia, or hemodynamic instability should be suspected of the failure of bypass grafts if accompanied by changes in the electrocardiogram (EKG) and an increase in myocardial enzymes. Intervention should be carried out as soon as possible after angiography detects graft failure to limit the occurrence of large-scale myocardial injury and prevent the development of severe myocardial failure. This study is start on June 1 2020. And will include 400 patients who have just undergone PCI and 300 CABG patients who diagnosis of stable coronary artery disease. We will register their medical history, medications, and routine medical examinations within one year, and perform tests such as phonocardiography (Audiocor). They will be worn and measured daily at home after discharge. The data of the electrocardiogram and the PPG bracelet will be registered with their continuous daily values. All subjects tracked the occurrence of adverse medical events within one year after discharge from the hospital. Based on the home-based remote personal care model for patients with CABG, a risk prediction model for heart failure and vascular restenosis was established to effectively reduce medical treatment, adverse events, and medical expenditure.
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 29, 2020
CompletedStudy Start
First participant enrolled
July 20, 2020
CompletedFirst Posted
Study publicly available on registry
July 24, 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 24, 2020
June 1, 2020
2 years
June 29, 2020
July 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
death
death, divided into yes or no
Within a year
Restenosis
Come back to the hospital for PCI or CABG or MI (Judged by the physician) after discharge, divided into yes or no
Within a year
heart failure
Come back to the hospital for heart failure (Judged by the physician) after discharge, divided into yes or no
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
Interventions
routine medical
Eligibility Criteria
Age\>=20,Physician diagnosed with stable coronary artery disease (CAD), accepting PCI patients with stents or CABG, and willing to sign the subject consent and cooperate with return. And random allocation 350 experimental group (Non-invasive Wearable Device) and 350 control group (routine medical).
You may qualify if:
- Age\>=20,Physician diagnosed with stable coronary artery disease (CAD), accepting PCI patients with stents or CABG, and willing to sign the subject consent and cooperate with return.
You may not qualify if:
- Not eligible
- Patients judged to be STEMI or NSTEMI by the physician
- PCI bracket
- Patients with severe skin damage near the electrode or sensor device.
- Failure to cooperate in signing consent
- Those who cannot be admitted to the hospital after the onset and have their first examination before the operation
- Unable to measure the ECG heart sounds. For example, if you use a heart rate regulator, the ECG will show ventricular tachycardia (VT) and Dextrocardia on admission.
- Patients who are bedridden and have difficulty in cooperating with return visits
- Direct participants in this plan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taipei Medical University Shuang Ho Hospitallead
- Taipei Medical University WanFang Hospitalcollaborator
- Taipei Medical University Hospitalcollaborator
- Lotung Poh-Ai Hospitalcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ju-Chi Liu, MD
Chief, Internal of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2020
First Posted
July 24, 2020
Study Start
July 20, 2020
Primary Completion
July 20, 2022
Study Completion
July 20, 2024
Last Updated
July 24, 2020
Record last verified: 2020-06