Home-based Remote Monitoring
QIBO
Quality Improvements in Post-Myocardial Infarction Management Using Home-Based RemOte Monitoring System (QIBO)
1 other identifier
interventional
344
1 country
1
Brief Summary
Acute myocardial infarction (MI) is a disease of high morbidity and mortality. It is usually caused by atherothrombosis of major epicardial coronary arteries which result in myocardial necrosis. Due to improvement in care systems, availability of revascularizations and better medical treatment, the mortality of MI has generally declined in the past 20 years. Nevertheless, patients survived MI are still at heightened risk of further cardiovascular events and death. Therefore, guideline directed secondary preventive measures are of paramount importance to improve long term outcome. These include adherence to medications and dose titration, risk factor modification, detection of arrhythmia and use of implantable cardio-defibrillator (ICD) as appropriate. In reality, guideline adherence is unsatisfactory and may lead to worse clinical outcomes. The underlying reasons are multi-factorial, including lack of patient education, recognition, motivation or physician inertia. Therefore, newer initiatives are required to reinforce secondary preventive measures. In current era of health information technology, remote monitoring and telecommunication emerge to be practice-changing in various aspects of healthcare provision. Particularly for post MI survivors, the early post discharge period is vulnerable and a significant number of patients are readmitted 30 days after leaving hospital. This is not surprising as patients are still in recovering phase on medications titration and many of them may not fully accept they are suffering from a life-threatening condition. Besides, malignant arrhythmia may develop without the protection of ICD which is usually implanted after 40 days post MI as per clinical guidelines. As such, home-based remote monitoring with handheld single-lead electrocardiogram and patch-based continuous holter monitor can potentially detect arrhythmia which prompt early clinical attention. Furthermore, daily blood pressure measurement using dedicated smartphone applications enables physicians and patients to up-titrate medications to desired doses more quickly. This can hopefully strengthen compliance to better achieve guideline recommended treatment targets. In the Quality Improvements in Post-Myocardial Infarction Management using Home-Based RemOte Monitoring System trial (QIBO; "岐伯" in Chinese), we investigate the feasibility and efficacy of utilizing a home-based remote monitoring system in post MI survivors. We hypothesize that this approach is effective to improve guideline directed treatment utility, cardiovascular risk factors target achievement and clinical outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
March 25, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedMarch 25, 2022
March 1, 2022
3 years
March 15, 2022
March 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Renin-angiotensin-aldosterone system blockers
Percentage of patients with ≥50% maximal targeted dose (MTD) of renin-angiotensin-aldosterone system blockers
17 weeks
Secondary Outcomes (22)
Beta-adrenergic blockers
17 weeks
Ivabradine
17 weeks
Statin
17 weeks
Renin-angiotensin-aldosterone system blockers
17 weeks
Beta-adrenergic blockers
17 weeks
- +17 more secondary outcomes
Study Arms (2)
Interventional group
EXPERIMENTALSubjects will be provided with a home-based remote integrated post-MI management system and will be instructed to perform daily routine measurements. Site investigators will review the physiological parameters of patients randomized to the Intervention group daily and treatment can be initiated or modified accordingly through instant communication (electronic communication and/or phone).
Control group
PLACEBO COMPARATORSubjects will be provided with a home-based remote integrated post-MI management system and will be instructed to perform daily routine measurements. Site investigators will review individual patient physiological parameters and risk factors only during the clinic visits
Interventions
The home-based remote integrated post-MI management system comprises (1) a patch-based long-term Holter monitoring system HC3A250 (BISA Technologies (Hong Kong) Limited, Hong Kong SAR, China), (2) a handheld single-lead electrocardiogram (ECG) recorder (Comfit Healthcare Devices Limited, Hong Kong SAR, China), (3) a blood pressure monitor, (4) a patient-facing smartphone application specially designed for the study, and (5) a web-based clinical management system for clinicians
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Hospitalized with acute myocardial infarction as defined as a detection of a rise and/or fall of troponin with at least 1 value above the 99th percentile upper reference limit together with either (1) symptoms of myocardial ischemia, or (2) ECG changes compatible with myocardial ischemia
- Treated with PCI for culprit lesson
- Voluntarily agrees to participate by providing written informed consent
You may not qualify if:
- Complex congenital heart disease
- Significant valvular stenosis
- Left ventricular assist device
- Listed for heart transplant
- Renal impairment with serum creatinine ≥ 190 μmol/L or on renal replacement therapy
- Inability or refusal to provide inform consent
- Short life expectance (\< 1 year) due to concomitant medical condition(s)
- Lack of skills in operating simple electronic devices
- Unavailability of a mobile network service in the place of residence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chung-Wah David Siu, Prof
The University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
March 15, 2022
First Posted
March 25, 2022
Study Start
July 1, 2022
Primary Completion
June 30, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
March 25, 2022
Record last verified: 2022-03