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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04664881
Other study ID # 20-001646
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2020
Est. completion date May 2, 2024

Study information

Verified date June 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 195
Est. completion date May 2, 2024
Est. primary completion date May 2, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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 90 days after hospital discharge
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