Home Telemonitoring In Patients After Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

Home Telemonitoring In Patients After Myocardial Infarction, HELP ME Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04664881
• Other study ID #: 20-001646
• Status: Completed
• Phase: N/A
• Start date: October 14, 2020
• Est. completion date: May 2, 2024

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: May 2, 2024
• Est. primary completion date: May 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Attack
• Infarction
• Myocardial Infarction

Intervention

Device:
• SmartHeart Device
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials