Home-based Remote Monitoring (QIBO)

Quality Improvements in Post-Myocardial Infarction Management Using Home-Based RemOte Monitoring System (QIBO)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Infarction
• Intervention / Treatment: Device: Remote integrated post-MI management system

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 Type: Interventional
• Enrollment (Anticipated): 344
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chun-Ka Wong, Resident; Phone Number: +852-22553597; Email: emmanuelckwong@gmail.com

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong, Queen Mary Hospital
    • Contact: Chung-Wah David Siu, Professor; Phone Number: 22553597; Email: cwdsiu@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renin-angiotensin-aldosterone system blockers	Percentage of patients with ≥50% maximal targeted dose (MTD) of renin-angiotensin-aldosterone system blockers	17 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beta-adrenergic blockers	Percentage of patients with ≥50% maximal targeted dose (MTD) of beta-adrenergic blocker2	17 weeks
Ivabradine	Percentage of patients with ≥50% maximal targeted dose (MTD) of ivabradine	17 weeks
Statin	Percentage of patients with ≥50% maximal targeted dose (MTD) of statin	17 weeks
Renin-angiotensin-aldosterone system blockers	Dosage in terms of percentage maximal targeted dose (MTD) of renin-angiotensin-aldosterone system blockers	17 weeks
Beta-adrenergic blockers	Dosage in terms of percentage maximal targeted dose (MTD) of beta-adrenergic blockers	17 weeks
Ivabradine	Dosage in terms of percentage maximal targeted dose (MTD) of ivabradine	17 weeks
Statin	Dosage in terms of percentage maximal targeted dose (MTD) of statin	17 weeks
Low density lipoprotein	Occurrence of achieving cardiovascular risk factors target of low density lipoprotein (< 1.4 mmol/L or >50% reduction)	17 weeks
High density lipoprotein	Occurrence of achieving cardiovascular risk factors target of high density lipoprotein (> 1.0 mmol/L)	17 weeks
Triglyceride	Occurrence of achieving cardiovascular risk factors target of triglyceride (< 1.7 mmol/L)	17 weeks
Body mass index	Occurrence of achieving cardiovascular risk factors target of body mass index (< 25 kg/m2)	17 weeks
Resting blood pressure	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)	17 weeks
Resting heart rate	Occurrence of achieving cardiovascular risk factors target of resting heart rate (sinus rhythm 50 - 70 bpm and atrial fibrillation 50 - 110 bpm)	17 weeks
Hemoglobin A1C	Occurrence of achieving cardiovascular risk factors target of hemoglobin A1c (< 7%)	17 weeks
Smoking cessation	Occurrence of achieving cardiovascular risk factors target of smoking cessation	17 weeks
Moderate intensity aerobic exercise	Occurrence of achieving cardiovascular risk factors target of moderate intensity aerobic exercise (> equivalent of 30 minutes for 5 times per week)	17 weeks
Major adverse cardiovascular events	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	17 weeks
Heart failure hospitalization	Occurrence of cardiovascular events of heart failure hospitalization	17 weeks
New-onset atrial fibrillation	Occurrence of cardiovascular events of new-onset atrial fibrillation	17 weeks
Sudden cardiac arrest	Occurrence of cardiovascular events of sudden cardiac arrest	17 weeks
Implantation of automatic implantable cardioverter-defibrillator	Occurrence of cardiovascular events of implantation of automatic implantable cardioverter-defibrillator	17 weeks
All cause mortality	Occurrence of cardiovascular events of all cause mortality	17 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): June 30, 2026

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: QIBO_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No