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Home Telemonitoring In Patients After Myocardial Infarction

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Mayo Clinic

Status

Completed

Conditions

Heart Attack
Myocardial Infarction

Treatments

Device: SmartHeart Device

Study type

Interventional

Funder types

Other

Identifiers

NCT04664881
20-001646

Details and patient eligibility

About

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.

Enrollment

195 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

195 participants in 2 patient groups

Control (standard treatment) Group
No Intervention group
Description:
Participants will receive routine cardiac treatment
SmartHeart Device Group
Experimental group
Description:
In addition to routine cardiac treatment, participants will wear the SmartHeart device
Treatment:
Device: SmartHeart Device

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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