QIBO: Home-based Remote Monitoring

Sponsor
The University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05295303
Collaborator
(none)
344
1
2
48
7.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Remote integrated post-MI management system
N/A

Detailed Description

This is a prospective, multi-center, open-labelled, randomized controlled trial. Patients with acute myocardial infarction with primary or early percutaneous coronary intervention (PCI) will be recruited upon hospital discharge. Patients with ST-segment elevation myocardial infarction (STEMI) and non-STEMI will be randomized in a 1:1 ratio to home-based remote management care (Intervention group) or conventional care (Control group) for 17 weeks.

Upon hospital discharge, all patients will be provided with a home-based remote integrated post-MI management system and will be instructed to perform daily routine measurements. Patients randomized to the Intervention group will be given patch-based Holter ECG monitoring till post-MI day 40.

The home-based remote integrated post-MI management system comprises (1) a patch-based long-term Holter monitoring system, (2) a handheld single-lead electrocardiogram (ECG) recorder, (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.

All remotely obtained Holter data will be transferred daily via the study smartphone application to detect (1) ventricular arrhythmia, (2) ST-segment change, and (3) atrial fibrillation. Thereafter patients in the Interventional group will be instructed to record a 30-second single-lead ECG using the handheld ECG device every morning or when symptomatic. Patients in both the Intervention group and Control group will be instructed to measure their blood pressure in the morning and evening and input the data through the study smartphone application. All remotely obtained physiological data will be automatically transmitted in real-time to a secured cloud hosting and displayed on a web-based dashboard at the clinicians' offices. Physiological parameters of patients in the Interventional group will be reviewed daily by site investigators with preset algorithms to titrate or modify guideline directed medical therapy through instant communication (electronic communication and/or phone), whereas for the Control group, patient data will be reviewed only at the clinic visits. All patients will be followed up for 17 weeks.

There will have instruction session for study participants, a study research nurse will educate them on individual cardiovascular risk factors, life-style modification, and the treatment targets. In addition, the risk of recurrent cardiovascular event will be estimated using the Thrombolysis In Myocardial Infarction (TIMI) Risk Score for Secondary Prevention (TRS 2°P) score. The TRS 2°P incorporates 9 readily available clinical characteristics: congestive heart failure, hypertension, diabetes mellitus, age ≥75 years, prior stroke, prior coronary artery bypass graft, peripheral artery disease, estimated glomerular filtration rate <60, and smoking to predict recurrent cardiovascular events.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
344 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
To assess efficacy of home-based remote monitoring in post-myocardial infarction patient for improving guideline directed treatment utility, compared between subjects with home-based remote monitoring and management care (Interventional group) and conventional care (Control group).To assess efficacy of home-based remote monitoring in post-myocardial infarction patient for improving guideline directed treatment utility, compared between subjects with home-based remote monitoring and management care (Interventional group) and conventional care (Control group).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Quality Improvements in Post-Myocardial Infarction Management Using Home-Based RemOte Monitoring System (QIBO)
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interventional group

Subjects 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).

Device: Remote integrated post-MI management system
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
Other Names:
  • Holter monitoring system HC3A250 (BISA Technologies (Hong Kong) Limited, Hong Kong SAR, China)
  • Single-lead electrocardiogram (ECG) recorder (Comfit Healthcare Devices Limited, Hong Kong SAR, China)
  • Placebo Comparator: Control group

    Subjects 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

    Device: Remote integrated post-MI management system
    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
    Other Names:
  • Holter monitoring system HC3A250 (BISA Technologies (Hong Kong) Limited, Hong Kong SAR, China)
  • Single-lead electrocardiogram (ECG) recorder (Comfit Healthcare Devices Limited, Hong Kong SAR, China)
  • Outcome Measures

    Primary Outcome Measures

    1. Renin-angiotensin-aldosterone system blockers [17 weeks]

      Percentage of patients with ≥50% maximal targeted dose (MTD) of renin-angiotensin-aldosterone system blockers

    Secondary Outcome Measures

    1. Beta-adrenergic blockers [17 weeks]

      Percentage of patients with ≥50% maximal targeted dose (MTD) of beta-adrenergic blocker2

    2. Ivabradine [17 weeks]

      Percentage of patients with ≥50% maximal targeted dose (MTD) of ivabradine

    3. Statin [17 weeks]

      Percentage of patients with ≥50% maximal targeted dose (MTD) of statin

    4. Renin-angiotensin-aldosterone system blockers [17 weeks]

      Dosage in terms of percentage maximal targeted dose (MTD) of renin-angiotensin-aldosterone system blockers

    5. Beta-adrenergic blockers [17 weeks]

      Dosage in terms of percentage maximal targeted dose (MTD) of beta-adrenergic blockers

    6. Ivabradine [17 weeks]

      Dosage in terms of percentage maximal targeted dose (MTD) of ivabradine

    7. Statin [17 weeks]

      Dosage in terms of percentage maximal targeted dose (MTD) of statin

    8. Low density lipoprotein [17 weeks]

      Occurrence of achieving cardiovascular risk factors target of low density lipoprotein (< 1.4 mmol/L or >50% reduction)

    9. High density lipoprotein [17 weeks]

      Occurrence of achieving cardiovascular risk factors target of high density lipoprotein (> 1.0 mmol/L)

    10. Triglyceride [17 weeks]

      Occurrence of achieving cardiovascular risk factors target of triglyceride (< 1.7 mmol/L)

    11. Body mass index [17 weeks]

      Occurrence of achieving cardiovascular risk factors target of body mass index (< 25 kg/m2)

    12. Resting blood pressure [17 weeks]

      Occurrence of achieving cardiovascular risk factors target of resting blood pressure (systolic blood pressure within 100 - 120 mmHg and diastolic blood pressure within 60 - 90 mmHg)

    13. Resting heart rate [17 weeks]

      Occurrence of achieving cardiovascular risk factors target of resting heart rate (sinus rhythm 50 - 70 bpm and atrial fibrillation 50 - 110 bpm)

    14. Hemoglobin A1C [17 weeks]

      Occurrence of achieving cardiovascular risk factors target of hemoglobin A1c (< 7%)

    15. Smoking cessation [17 weeks]

      Occurrence of achieving cardiovascular risk factors target of smoking cessation

    16. Moderate intensity aerobic exercise [17 weeks]

      Occurrence of achieving cardiovascular risk factors target of moderate intensity aerobic exercise (> equivalent of 30 minutes for 5 times per week)

    17. Major adverse cardiovascular events [17 weeks]

      Occurrence of cardiovascular events of composite major adverse cardiovascular events including cardiovascular death from any causes, non-fatal myocardial infarction, unplanned coronary revascularization, and non-fatal stroke

    18. Heart failure hospitalization [17 weeks]

      Occurrence of cardiovascular events of heart failure hospitalization

    19. New-onset atrial fibrillation [17 weeks]

      Occurrence of cardiovascular events of new-onset atrial fibrillation

    20. Sudden cardiac arrest [17 weeks]

      Occurrence of cardiovascular events of sudden cardiac arrest

    21. Implantation of automatic implantable cardioverter-defibrillator [17 weeks]

      Occurrence of cardiovascular events of implantation of automatic implantable cardioverter-defibrillator

    22. All cause mortality [17 weeks]

      Occurrence of cardiovascular events of all cause mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Hong Kong, Queen Mary Hospital Hong Kong Hong Kong

    Sponsors and Collaborators

    • The University of Hong Kong

    Investigators

    • Principal Investigator: Chung-Wah David Siu, Prof, The University of Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Chung-Wah David SIU, Clinical Professor, The University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT05295303
    Other Study ID Numbers:
    • QIBO_1
    First Posted:
    Mar 25, 2022
    Last Update Posted:
    Mar 25, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 25, 2022