Home Telemonitoring In Patients After Myocardial Infarction

Not Applicable

Completed

• Conditions: Myocardial Infarction; Heart Attack
• Interventions: Device: SmartHeart Device

• Registration Number: NCT04664881
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-14
• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-11
• Primary Completion: 2024-05-02
• Study Completion: 2024-05-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SmartHeart Device Group	SmartHeart Device	In addition to routine cardiac treatment, participants will wear the SmartHeart device

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events	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
Emergency Room Visits	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	90 days after hospital discharge	Number of re-hospitalizations over a period of 90 days after an index hospitalization for an acute myocardial infarction
Mortality rate	90 days after hospital discharge	Number of deaths over a period of 90 days after an index hospitalization for an acute myocardial infarction

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States