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Home Telemonitoring In Patients After Myocardial Infarction

Primary Purpose

Myocardial Infarction, Heart Attack

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SmartHeart Device
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥ 18 years of age.
  • 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.
  • Planned to be discharged home by the treating team.

Exclusion Criteria:

  • No ability to use the device at home
  • 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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control (standard treatment) Group

SmartHeart Device Group

Arm Description

Participants will receive routine cardiac treatment

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

Outcomes

Primary Outcome Measures

Emergency Room Visits
Number of emergency room visits over a period of 90 days after an index hospitalization for an acute myocardial infarction
Re-hospitalizations
Number of re-hospitalizations over a period of 90 days after an index hospitalization for an acute myocardial infarction
Mortality rate
Number of deaths over a period of 90 days after an index hospitalization for an acute myocardial infarction
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

Secondary Outcome Measures

Full Information

First Posted
December 7, 2020
Last Updated
August 14, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04664881
Brief Title
Home Telemonitoring In Patients After Myocardial Infarction
Official Title
Home Telemonitoring In Patients After Myocardial Infarction, HELP ME Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Heart Attack

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control (standard treatment) Group
Arm Type
No Intervention
Arm Description
Participants will receive routine cardiac treatment
Arm Title
SmartHeart Device Group
Arm Type
Experimental
Arm Description
In addition to routine cardiac treatment, participants will wear the SmartHeart device
Intervention Type
Device
Intervention Name(s)
SmartHeart Device
Intervention Description
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 Outcome Measure Information:
Title
Emergency Room Visits
Description
Number of emergency room visits over a period of 90 days after an index hospitalization for an acute myocardial infarction
Time Frame
90 days after hospital discharge
Title
Re-hospitalizations
Description
Number of re-hospitalizations over a period of 90 days after an index hospitalization for an acute myocardial infarction
Time Frame
90 days after hospital discharge
Title
Mortality rate
Description
Number of deaths over a period of 90 days after an index hospitalization for an acute myocardial infarction
Time Frame
90 days after hospital discharge
Title
Major Adverse Cardiovascular Events
Description
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
Time Frame
90 days after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joerg Herrmann, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Home Telemonitoring In Patients After Myocardial Infarction

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