Myocardial InfarctionNCT04664881
Home Telemonitoring In Patients After Myocardial Infarction
A study testing SmartHeart Device in people with Myocardial Infarction and Heart Attack, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Heart Attack
- What is being tested?
- SmartHeart Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2020to 2 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Home Telemonitoring In Patients After Myocardial Infarction, HELP ME Trial
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
- Being tested
- SmartHeart Device
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartHeart DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: SmartHeart Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Room Visits
Number of emergency room visits over a period of 90 days after an index hospitalization for an acute myocardial infarction
Measured: 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
Measured: 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
Measured: 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
Measured: 90 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start14 Oct 2020
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joerg Herrmann, MD, Mayo Clinic
- Investigators
- Joerg Herrmann, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664881
- Sponsor's protocol ID
- 20-001646
- Status last verified
- Apr 2025
- First submitted
- 7 Dec 2020
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Telemonitoring In Patients After Myocardial Infarction, HELP ME Trial
- ClinicalTrials.gov ID
- NCT04664881
- Acronym / sponsor ID
- 20-001646
- Conditions
- Myocardial Infarction, Heart Attack
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Posted 11 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (standard treatment) Group | No intervention | –Participants will receive routine cardiac treatment |
| SmartHeart Device Group | Experimental | Device: SmartHeart DeviceIn addition to routine cardiac treatment, participants will wear the SmartHeart device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartHeart DeviceA 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. | Device | SmartHeart Device Group |
Primary outcome
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joerg Herrmann, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartHeart Device in people with Myocardial Infarction and Heart Attack, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency Room Visits (time frame: 90 days after hospital discharge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.