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OpenTrials
Completed

NCT Number: NCT04664881

Home Telemonitoring In Patients After Myocardial Infarction

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Attack Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SmartHeart Device

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Home Telemonitoring In Patients After Myocardial Infarction, HELP ME Trial

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 11, 2020
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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