Home Telemonitoring In Patients After Myocardial Infarction

Study Overview
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Brief Summary
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This study is being done to determine if taking an electrocardiogram (ECG) by a portable device (SmartHeart) followed by a phone call will improve patient outcomes by early recognition of abnormalities and decrease emergency room visits and hospital readmissions compared to standard therapy alone.

Official Title
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Home Telemonitoring In Patients After Myocardial Infarction, HELP ME Trial

Conditions
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Myocardial Infarction, Heart Attack

Intervention / Treatment
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* Device: SmartHeart Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute myocardial infarction, both STEMI and non-STEMI. Able to use the home ECG telemonitoring. Must have smartphone device with home wi-fi/mobile internet which allows for 24/7 ability to transmit ECG. Caring family member who will be able to help/perform the ECG in case the patient won't be able to do it. Exclusion Criteria: No ability to use the device at home/unable to comply with the device instructions No smartphone device or home wi-fi/mobile internet which prevent 24/7 ability to transmit ECG Cannot download the smartheart app No support in home environment Out of hospital cardiac arrest: secondary to a non-shockable rhythm, unrelated to an acute coronary syndrome, or with any level of neurologic damage. Resident of nursing home or acute care facility Uninterpretable ECG at discharge - left bundle branch block (LBBB), pacemaker or implantable cardioverter defibrillator (ICD) with pacing dependence. Patients who are planned for staged PCI after the index hospitalization

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control (standard treatment) Group<br>Participants will receive routine cardiac treatment | |
| Experimental: SmartHeart Device Group<br>In addition to routine cardiac treatment, participants will wear the SmartHeart device | Device: SmartHeart Device<br>* A body-worn device that allows an individual to immediately transmit a 12-lead ECG from anywhere and anytime, using a smartphone application to a physician's office, hospital or monitoring center where designated on-call staff interpret the ECG and make recommendations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency Room Visits | Number of emergency room visits over a period of 90 days after an index hospitalization for an acute myocardial infarction | 90 days after hospital discharge | 
| Re-hospitalizations | Number of re-hospitalizations over a period of 90 days after an index hospitalization for an acute myocardial infarction | 90 days after hospital discharge | 
| Mortality rate | Number of deaths over a period of 90 days after an index hospitalization for an acute myocardial infarction | 90 days after hospital discharge | 
| Major Adverse Cardiovascular Events | Number of major adverse cardiovascular events including cardiovascular death and hospitalization for myocardial infarction, unstable angina, repeat revascularization, heart failure, stroke, arrhythmias, and cardiac arrest over a period of 90 days after an index hospitalization for an acute myocardial infarction | 90 days after hospital discharge |