Home Telemonitoring In Patients After Myocardial Infarction

NCT04664881 | Completed Results FDA Device

• 1 other identifier: 20-001646
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Heart Attack

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Control (standard treatment) Group

NO INTERVENTION

Participants will receive routine cardiac treatment

SmartHeart Device Group

EXPERIMENTAL

In addition to routine cardiac treatment, participants will wear the SmartHeart device

Device: SmartHeart Device

Interventions

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.

SmartHeart Device Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Joerg Herrmann, M.D.
• Organization: Mayo Clinic

Herrmann.Joerg@mayo.edu

507-255-1267

Study Officials

• Joerg Herrmann, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 11, 2020
• Study Start: October 14, 2020
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: May 11, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)