Home Telemonitoring In Patients After Myocardial Infarction, HELP ME Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myocardial Infarction
- Sponsor
- Mayo Clinic
- Enrollment
- 195
- Locations
- 1
- Primary Endpoint
- Mortality Rate
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Investigators
Joerg Herrmann, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
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
Outcomes
Primary Outcomes
Mortality Rate
Time Frame: 90 days after hospital discharge
Number of deaths over a period of 90 days after an index hospitalization for an acute myocardial infarction
Emergency Room Visits
Time Frame: 90 days after hospital discharge
Number of emergency room visits over a period of 90 days after an index hospitalization for an acute myocardial infarction
Re-hospitalizations
Time Frame: 90 days after hospital discharge
Number of re-hospitalizations over a period of 90 days after an index hospitalization for an acute myocardial infarction
Major Adverse Cardiovascular Events
Time Frame: 90 days after hospital discharge
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