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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joerg Herrmann, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control (Standard Treatment) Group | Participants received routine cardiac treatment |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control (Standard Treatment) Group | Participants received routine cardiac treatment |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Emergency Room Visits | Number of emergency room visits over a period of 90 days after an index hospitalization for an acute myocardial infarction | Posted | Number | Emergency Room Visits | 90 days after hospital discharge |
|
Adverse events were collected from patient consent through study completion, approximately 90 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control (Standard Treatment) Group | Participants received routine cardiac treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Cardiac Chest Pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joerg Herrmann, M.D. | Mayo Clinic | 507-255-1267 | Herrmann.Joerg@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 27, 2024 | Apr 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| Lost to Follow-up |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| Primary | Re-hospitalizations | Number of re-hospitalizations over a period of 90 days after an index hospitalization for an acute myocardial infarction | Posted | Number | Re-Hospitalizations | 90 days after hospital discharge |
|
|
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| Primary | Mortality Rate | Number of deaths over a period of 90 days after an index hospitalization for an acute myocardial infarction | Posted | Count of Participants | Participants | 90 days after hospital discharge |
|
|
|
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| 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 | The study team did not collect stroke data on any of the participants. | Posted | Number | events | 90 days after hospital discharge |
|
|
|
|
| 4 |
| 98 |
| 3 |
| 98 |
| 24 |
| 98 |
| EG001 | 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. | 3 | 97 | 6 | 97 | 22 | 97 |
| Arrhythmias | Cardiac disorders | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
|
| Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Repeat Revascularization | Cardiac disorders | Systematic Assessment |
|
| Unstable Angina | Cardiac disorders | Systematic Assessment |
|
| Rapid Heart Rate | Cardiac disorders | Systematic Assessment |
|
| Peripheral Edema | General disorders | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Scalp Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| General Weakness | General disorders | Systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Angioedema | Immune system disorders | Systematic Assessment |
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| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Shoulder Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Numbness and Tingling in Extremity | Nervous system disorders | Systematic Assessment |
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| Pain and Swelling in Hand | General disorders | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
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| Elevated Blood Pressure | Surgical and medical procedures | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Gastrointestional Hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Idiopathic Generalized Epilepsy | Nervous system disorders | Systematic Assessment |
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| Fibula Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pelvic Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Swelling over Left Supraorbital Area | Injury, poisoning and procedural complications | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
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| Mechanical Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Malignant Neoplasm of Colon | Gastrointestinal disorders | Systematic Assessment |
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| Allergic Reaction | Immune system disorders | Systematic Assessment |
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| Supraventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| Unstable Angia |
|
| Repeat Revascularization |
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| Heart Failure |
|
| Arrhythmias |
|
| Cardiac Arrest |
|
| 0.36 |
| Superiority |
| Arrhythmias | Chi-squared, Corrected | 0.13 | Superiority |
| Cardiac Arrest | Chi-squared, Corrected | 0.99 | Superiority |