Cloud-based ECG Monitoring and Healthcare Model Building on the Population With Coronary Artery Revascularization

Coronary Artery Disease Clinical Trial

Official title:

Cloud-based ECG Monitoring and Healthcare Model Building on the Population With Coronary Artery Revascularization

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04485143
• Other study ID #: N202005037
• Status: Not yet recruiting
• Start date: July 20, 2020
• Est. completion date: July 20, 2024

Study information

• Verified date: June 2020
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: Ju-Chi Liu, MD
• Phone: 886-2-22490088
• Email: liumdcv[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

This study is open, prospective study, multi-center, randomized controlled trial, unobtrusive research. 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. And random allocation 350 experimental group (Non-invasive Wearable Device) and 350 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 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft
• Coronary Artery Disease
• Percutaneous Coronary Intervention

Intervention

Device:
• Wisdom bracelet
routine medical

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital	Lotung Poh-Ai Hospital, Taipei Medical University Hospital, Taipei Medical University WanFang Hospital

Outcome

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