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N/A N=195 Randomized Supportive Care

Home Telemonitoring In Patients After Myocardial Infarction

Myocardial Infarction · Heart Attack

Bottom Line

View on ClinicalTrials.gov: NCT04664881 ↗
Enrolled (actual)
195
Serious AEs
4.6%
Results posted
May 2025
Primary outcome: Primary: Emergency Room Visits — 40; 33 Emergency Room Visits

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SmartHeart Device (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Mayo Clinic
Primary completion
May 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Emergency Room Visits		 40; 33 —
PRIMARY
Re-hospitalizations		 9; 11 —
PRIMARY
Mortality Rate		 4; 3 0.71
PRIMARY
Major Adverse Cardiovascular Events		 1; 2; 1; 4; 0; 0 0.99

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04664881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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