Coronary Artery DiseaseNCT04485143
Cloud-based ECG Monitoring and Healthcare Model Building on the Population With Coronary Artery Revascularization
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Taipei Medical University Shuang Ho Hospital.
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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention, Coronary Artery Bypass Graft
- What is being tested?
- Wisdom bracelet
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2020to 20 Jul 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
- 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
- Direct participants in this plan
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- Wisdom bracelet
- Keywords
- Percutaneous Coronary Intervention, Coronary Artery Bypass, Phonocardiography, PPG, Bracelet, Vascular Restenosis, Artificial intelligence
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wisdom braceletDevice
Also called control group (routine medical)
routine medical
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Non-invasive Wearable Device Receives: Device: Wisdom bracelet |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
death, divided into yes or no
Measured: 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
Measured: Within a year
heart failure
Come back to the hospital for heart failure (Judged by the physician) after discharge, divided into yes or no
Measured: Within a year
Secondary outcomes (7)
heart disease re-hospitalization
Re-hospitalization for heart disease (Judged by the physician) after discharge, divided into yes or no
Measured: Within a year
Stroke re-hospitalization
Re-hospitalization for Stroke (Judged by the physician) after discharge, divided into yes or no
Measured: Within a year
Arrhythmia re-hospitalization
Re-hospitalization for Arrhythmia (Judged by the physician) after discharge, divided into yes or no
Measured: Within a year
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
Measured: Within a year
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
Measured: Within a year
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
Measured: Within a year
Medical cost
The sum of all medical and health insurance expenses of the patient in the past year
Measured: Within a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start20 Jul 2020 (estimated)
- Primary completion20 Jul 2022 (estimated)
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital, Taipei Medical University Hospital, Lotung Poh-Ai Hospital
- Responsible party
- Sponsor
- Investigators
- Ju-Chi Liu, MD, Study chair, Chief, Internal of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485143
- Sponsor's protocol ID
- N202005037
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cloud-based ECG Monitoring and Healthcare Model Building on the Population With Coronary Artery Revascularization
- ClinicalTrials.gov ID
- NCT04485143
- Acronym / sponsor ID
- N202005037
- Keywords
- Percutaneous Coronary Intervention, Coronary Artery Bypass, Phonocardiography, PPG, Bracelet, Vascular Restenosis, Artificial intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital, Taipei Medical University Hospital, Lotung Poh-Ai Hospital
- Study start
- 20 Jul 2020 (estimated)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Device: Wisdom braceletNon-invasive Wearable Device |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wisdom braceletAlso: control group (routine medical)routine medical | Device | experimental group |
Primary outcome
death
Time frame: Within a year
death, divided into yes or no
Restenosis
Time frame: Within a year
Come back to the hospital for PCI or CABG or MI (Judged by the physician) after discharge, divided into yes or no
heart failure
Time frame: Within a year
Come back to the hospital for heart failure (Judged by the physician) after discharge, divided into yes or no
7 secondary outcomes
heart disease re-hospitalization
Time frame: Within a year
Stroke re-hospitalization
Time frame: Within a year
Arrhythmia re-hospitalization
Time frame: Within a year
Physician adjusts medicine
Time frame: Within a year
Physician arranges examination early
Time frame: Within a year
Compliance
Time frame: Within a year
Medical cost
Time frame: Within a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju-Chi Liu, MD study chair
Chief, Internal of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Taipei Medical University Shuang Ho Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ju-Chi Liu, MD (886-2-22490088 ext. 8170, liumdcv@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: Within a year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.