Clinical trial NCT04485143: Cloud-based ECG Monitoring and Healthcare Model Building on the Population With Coronary Artery Revascularization
Official title: Cloud-based ECG Monitoring and Healthcare Model Building on the Population With Coronary Artery Revascularization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention
Coronary Artery Bypass Graft
Keywords: Percutaneous Coronary Intervention
Coronary Artery Bypass
Phonocardiography, PPG
Bracelet
Vascular Restenosis
Artificial intelligence
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
Collaborators: name: Taipei Medical University WanFang Hospital
name: Taipei Medical University Hospital
name: Lotung Poh-Ai Hospital
First posted: 2020-07-24
Enrollment: 700
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: death
timeFrame: Within a year
measure: Restenosis
timeFrame: Within a year
measure: heart failure
timeFrame: Within a year
Secondary outcomes:
measure: heart disease re-hospitalization
timeFrame: Within a year
measure: Stroke re-hospitalization
timeFrame: Within a year
measure: Arrhythmia re-hospitalization
timeFrame: Within a year
measure: Physician adjusts medicine
timeFrame: Within a year
measure: Physician arranges examination early
timeFrame: Within a year
measure: Compliance
timeFrame: Within a year
measure: Medical cost
timeFrame: Within a year
Other outcomes:
Locations:
Study officials:
affiliation: Chief, Internal of Medicine
name: Ju-Chi Liu, MD
role: STUDY_CHAIR
References: