Trial Outcomes & Findings for Home Telemonitoring In Patients After Myocardial Infarction (NCT NCT04664881)

Last Updated: 2025-05-11

Results Overview

Number of emergency room visits over a period of 90 days after an index hospitalization for an acute myocardial infarction

Recruitment status

COMPLETED

Study phase

Target enrollment

195 participants

Primary outcome timeframe

90 days after hospital discharge

Results posted on

2025-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Control (Standard Treatment) Group Participants received routine cardiac treatment	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.
Overall Study STARTED	98	97
Overall Study COMPLETED	96	84
Overall Study NOT COMPLETED	2	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Control (Standard Treatment) Group Participants received routine cardiac treatment	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.
Overall Study Withdrawal by Subject	1	8
Overall Study Physician Decision	0	5
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Home Telemonitoring In Patients After Myocardial Infarction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control (Standard Treatment) Group n=98 Participants Participants received routine cardiac treatment	SmartHeart Device Group n=97 Participants 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.	Total n=195 Participants Total of all reporting groups
Age, Continuous	62.2 years STANDARD_DEVIATION 11.0 • n=5 Participants	60.9 years STANDARD_DEVIATION 10.2 • n=7 Participants	61.5 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	63 Participants n=7 Participants	128 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	91 Participants n=5 Participants	89 Participants n=7 Participants	180 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	96 Participants n=5 Participants	90 Participants n=7 Participants	186 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	98 participants n=5 Participants	97 participants n=7 Participants	195 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Control (Standard Treatment) Group n=98 Participants Participants received routine cardiac treatment	SmartHeart Device Group n=97 Participants 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.
Emergency Room Visits	40 Emergency Room Visits	33 Emergency Room Visits

PRIMARY outcome

Timeframe: 90 days after hospital discharge

Number of re-hospitalizations over a period of 90 days after an index hospitalization for an acute myocardial infarction

Outcome measures

Outcome measures
Measure	Control (Standard Treatment) Group n=98 Participants Participants received routine cardiac treatment	SmartHeart Device Group n=97 Participants 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.
Re-hospitalizations	9 Re-Hospitalizations	11 Re-Hospitalizations

PRIMARY outcome

Timeframe: 90 days after hospital discharge

Number of deaths over a period of 90 days after an index hospitalization for an acute myocardial infarction

Outcome measures

Outcome measures
Measure	Control (Standard Treatment) Group n=98 Participants Participants received routine cardiac treatment	SmartHeart Device Group n=97 Participants 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.
Mortality Rate	4 Participants	3 Participants

PRIMARY outcome

Timeframe: 90 days after hospital discharge

Population: The study team did not collect stroke data on any of the participants.

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

Outcome measures

Outcome measures
Measure	Control (Standard Treatment) Group n=98 Participants Participants received routine cardiac treatment	SmartHeart Device Group n=97 Participants 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.
Major Adverse Cardiovascular Events Cardiovascular Death	1 events	2 events
Major Adverse Cardiovascular Events Hospitalization for Myocardial infarction	1 events	4 events
Major Adverse Cardiovascular Events Unstable Angia	0 events	0 events
Major Adverse Cardiovascular Events Repeat Revascularization	0 events	0 events
Major Adverse Cardiovascular Events Heart Failure	0 events	0 events
Major Adverse Cardiovascular Events Arrhythmias	0 events	4 events
Major Adverse Cardiovascular Events Cardiac Arrest	1 events	2 events

Adverse Events

Control (Standard Treatment) Group

Serious events: 3 serious events

Other events: 24 other events

Deaths: 4 deaths

SmartHeart Device Group

Serious events: 6 serious events

Other events: 22 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Control (Standard Treatment) Group n=98 participants at risk Participants received routine cardiac treatment	SmartHeart Device Group n=97 participants at risk 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.
Cardiac disorders Hospitalization for Myocardial Infarction	2.0% 2/98 • Number of events 2 • Adverse events were collected from patient consent through study completion, approximately 90 days.	4.1% 4/97 • Number of events 6 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Cardiac disorders Arrhythmias	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	4.1% 4/97 • Number of events 4 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Cardiac disorders Cardiac Arrest	1.0% 1/98 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.	2.1% 2/97 • Number of events 2 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Cardiac disorders Heart Failure	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Cardiac disorders Repeat Revascularization	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Cardiac disorders Unstable Angina	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.

Other adverse events

Additional Information

Joerg Herrmann, M.D.

Mayo Clinic

Phone: 507-255-1267

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Control (Standard Treatment) Group n=98 participants at risk Participants received routine cardiac treatment	SmartHeart Device Group n=97 participants at risk 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.
General disorders Non-Cardiac Chest Pain	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	2.1% 2/97 • Number of events 2 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Cardiac disorders Rapid Heart Rate	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	1.0% 1/97 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.
General disorders Peripheral Edema	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	1.0% 1/97 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Cardiac disorders Chest Pain	8.2% 8/98 • Number of events 9 • Adverse events were collected from patient consent through study completion, approximately 90 days.	10.3% 10/97 • Number of events 10 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Skin and subcutaneous tissue disorders Rash	1.0% 1/98 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.	1.0% 1/97 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Cardiac disorders Palpitations	1.0% 1/98 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.	2.1% 2/97 • Number of events 2 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	1.0% 1/97 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Injury, poisoning and procedural complications Scalp Laceration	1.0% 1/98 • Number of events 2 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Infections and infestations Pneumonia	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	1.0% 1/97 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.
General disorders General Weakness	1.0% 1/98 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Musculoskeletal and connective tissue disorders Neck Pain	3.1% 3/98 • Number of events 3 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Immune system disorders Angioedema	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	1.0% 1/97 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	2.0% 2/98 • Number of events 2 • Adverse events were collected from patient consent through study completion, approximately 90 days.	1.0% 1/97 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Gastrointestinal disorders Diverticulitis	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	1.0% 1/97 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Infections and infestations Cellulitis	2.0% 2/98 • Number of events 2 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Musculoskeletal and connective tissue disorders Shoulder Pain	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	1.0% 1/97 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Nervous system disorders Numbness and Tingling in Extremity	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	1.0% 1/97 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.
General disorders Pain and Swelling in Hand	1.0% 1/98 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Metabolism and nutrition disorders Hyperkalemia	2.0% 2/98 • Number of events 2 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Injury, poisoning and procedural complications Bleeding	1.0% 1/98 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Surgical and medical procedures Elevated Blood Pressure	2.0% 2/98 • Number of events 2 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Nervous system disorders Dizziness	1.0% 1/98 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Gastrointestinal disorders Gastrointestional Hemorrhage	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	1.0% 1/97 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Nervous system disorders Idiopathic Generalized Epilepsy	1.0% 1/98 • Number of events 2 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Injury, poisoning and procedural complications Fibula Fracture	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	1.0% 1/97 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Injury, poisoning and procedural complications Pelvic Fracture	1.0% 1/98 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Injury, poisoning and procedural complications Swelling over Left Supraorbital Area	1.0% 1/98 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Hepatobiliary disorders Cholecystitis	1.0% 1/98 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Injury, poisoning and procedural complications Mechanical Fall	2.0% 2/98 • Number of events 2 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Gastrointestinal disorders Malignant Neoplasm of Colon	1.0% 1/98 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Immune system disorders Allergic Reaction	1.0% 1/98 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.	0.00% 0/97 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	1.0% 1/97 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Cardiac disorders Coronary Artery Disease	1.0% 1/98 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.	1.0% 1/97 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.
Nervous system disorders Syncope	0.00% 0/98 • Adverse events were collected from patient consent through study completion, approximately 90 days.	1.0% 1/97 • Number of events 1 • Adverse events were collected from patient consent through study completion, approximately 90 days.