Coronary Artery Disease Clinical Trial
Official title:
Cloud-based ECG Monitoring and Healthcare Model Building on the Population With Coronary Artery Revascularization
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.
Status | Not yet recruiting |
Enrollment | 700 |
Est. completion date | July 20, 2024 |
Est. primary completion date | July 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion 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. Exclusion Criteria: 1. Not eligible 2. Patients judged to be STEMI or NSTEMI by the physician 3. PCI bracket 4. Patients with severe skin damage near the electrode or sensor device. 5. Failure to cooperate in signing consent 6. Those who cannot be admitted to the hospital after the onset and have their first examination before the operation 7. 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. 8. Patients who are bedridden and have difficulty in cooperating with return visits 9. Any physician evaluation is not suitable for inclusion in the trial, and subjects who are at high risk in the future cannot cooperate with the follow-up 10. Direct participants in this plan |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University Shuang Ho Hospital | Lotung Poh-Ai Hospital, Taipei Medical University Hospital, Taipei Medical University WanFang Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | death | death, divided into yes or no | Within a year | |
Primary | 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 | |
Primary | 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 | heart disease re-hospitalization | Re-hospitalization for heart disease (Judged by the physician) after discharge, divided into yes or no | Within a year | |
Secondary | Stroke re-hospitalization | Re-hospitalization for Stroke (Judged by the physician) after discharge, divided into yes or no | Within a year | |
Secondary | Arrhythmia re-hospitalization | Re-hospitalization for Arrhythmia (Judged by the physician) after discharge, divided into yes or no | Within a year | |
Secondary | Physician adjusts medicine | According to the medicine order issued by the doctor, if there is any adjustment of the medicine, make a record,divided into yes or no | Within a year | |
Secondary | Physician arranges examination early | If the doctor has arranged to do Cardiac ultrasound or stress & redistribution myocardial perfusion scan with SPECT During non-table period, divided into yes or no | Within a year | |
Secondary | 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 yes or no | Within a year | |
Secondary | Medical cost | The sum of all medical and health insurance expenses of the patient in the past year | Within a year |
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