Heart Attack, Myocardial Infarction
Conditions
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.
Interventions
DEVICESmartHeart 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control (Standard Treatment) Group Participants received routine cardiac treatment | 98 |
| SmartHeart Device Group In addition to routine cardiac treatment, participants wore the SmartHeart 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. | 97 |
| Total | 195 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 0 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 8 |
Baseline characteristics
| Characteristic | Control (Standard Treatment) Group | Total | SmartHeart Device Group |
|---|---|---|---|
| Age, Continuous | 62.2 years STANDARD_DEVIATION 11 | 61.5 years STANDARD_DEVIATION 10.6 | 60.9 years STANDARD_DEVIATION 10.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 91 Participants | 180 Participants | 89 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) White | 96 Participants | 186 Participants | 90 Participants |
| Region of Enrollment United States | 98 participants | 195 participants | 97 participants |
| Sex: Female, Male Female | 33 Participants | 67 Participants | 34 Participants |
| Sex: Female, Male Male | 65 Participants | 128 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 98 | 3 / 97 |
| other Total, other adverse events | 24 / 98 | 22 / 97 |
| serious Total, serious adverse events | 3 / 98 | 6 / 97 |
Outcome results
Primary
Emergency Room Visits
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control (Standard Treatment) Group | Emergency Room Visits | 40 Emergency Room Visits |
| SmartHeart Device Group | Emergency Room Visits | 33 Emergency Room Visits |
Primary
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
Time frame: 90 days after hospital discharge
Population: The study team did not collect stroke data on any of the participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control (Standard Treatment) Group | Major Adverse Cardiovascular Events | Heart Failure | 0 events |
| Control (Standard Treatment) Group | Major Adverse Cardiovascular Events | Cardiac Arrest | 1 events |
| Control (Standard Treatment) Group | Major Adverse Cardiovascular Events | Cardiovascular Death | 1 events |
| Control (Standard Treatment) Group | Major Adverse Cardiovascular Events | Hospitalization for Myocardial infarction | 1 events |
| Control (Standard Treatment) Group | Major Adverse Cardiovascular Events | Unstable Angia | 0 events |
| Control (Standard Treatment) Group | Major Adverse Cardiovascular Events | Repeat Revascularization | 0 events |
| Control (Standard Treatment) Group | Major Adverse Cardiovascular Events | Arrhythmias | 0 events |
| SmartHeart Device Group | Major Adverse Cardiovascular Events | Cardiac Arrest | 2 events |
| SmartHeart Device Group | Major Adverse Cardiovascular Events | Heart Failure | 0 events |
| SmartHeart Device Group | Major Adverse Cardiovascular Events | Unstable Angia | 0 events |
| SmartHeart Device Group | Major Adverse Cardiovascular Events | Arrhythmias | 4 events |
| SmartHeart Device Group | Major Adverse Cardiovascular Events | Cardiovascular Death | 2 events |
| SmartHeart Device Group | Major Adverse Cardiovascular Events | Repeat Revascularization | 0 events |
| SmartHeart Device Group | Major Adverse Cardiovascular Events | Hospitalization for Myocardial infarction | 4 events |
Comparison: Cardiovascular Deathp-value: 0.99Chi-squared, Corrected
Comparison: Hospitalization for Myocardial Infarctionp-value: 0.36Chi-squared, Corrected
Comparison: Arrhythmiasp-value: 0.13Chi-squared, Corrected
Comparison: Cardiac Arrestp-value: 0.99Chi-squared, Corrected
Primary
Mortality Rate
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control (Standard Treatment) Group | Mortality Rate | 4 Participants |
| SmartHeart Device Group | Mortality Rate | 3 Participants |
p-value: 0.71Chi-squared, Corrected
Primary
Re-hospitalizations
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control (Standard Treatment) Group | Re-hospitalizations | 9 Re-Hospitalizations |
| SmartHeart Device Group | Re-hospitalizations | 11 Re-Hospitalizations |