Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04485143
Status:
UNKNOWN
Last Update Posted:
2020-07-24
First Post:
2020-06-29
Brief Title:
Cloud-based ECG Monitoring and Healthcare Model Building on the Population With Coronary Artery Revascularization
Sponsor:
Taipei Medical University Shuang Ho Hospital
Organization:
Taipei Medical University Shuang Ho Hospital
Study Overview
Official Title:
Cloud-based ECG Monitoring and Healthcare Model Building on the Population With Coronary Artery Revascularization
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None