Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Home Telemonitoring In Patients After Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04664881
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : February 18, 2022
Sponsor:
Information provided by (Responsible Party):
Joerg Herrmann, MD, Mayo Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Heart Attack Device: SmartHeart Device Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Home Telemonitoring In Patients After Myocardial Infarction, HELP ME Trial
Actual Study Start Date : October 14, 2020
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Emergency Room Visits [ Time Frame: 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

  2. Re-hospitalizations [ Time Frame: 90 days after hospital discharge ]
    Number of re-hospitalizations over a period of 90 days after an index hospitalization for an acute myocardial infarction

  3. Mortality rate [ Time Frame: 90 days after hospital discharge ]
    Number of deaths over a period of 90 days after an index hospitalization for an acute myocardial infarction

  4. Major Adverse Cardiovascular Events [ Time Frame: 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664881


Contacts
Layout table for location contacts
Contact: Jacob W Bjerke 507-422-0467 Bjerke.Jacob@mayo.edu

Locations
Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jacob Bjerke    504-422-0467    Bjerke.Jacob@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Joerg Herrmann, MD Mayo Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Joerg Herrmann, MD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04664881    
Other Study ID Numbers: 20-001646
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: February 18, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases