Home Telemonitoring In Patients After Myocardial Infarction

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-14

Study Completion Date

2024-05-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Smartphone Twelve Lead Electrocardiogram Utility In ST Elevation Myocardial Infarction

NCT04057404

ST Elevated Myocardial Infarction

COMPLETED

Evaluation of MRI-conditional 12-lead ECG

NCT04247685

Atrial Fibrillation

RECRUITING NA

Tele-Electrocardiography in Emergency Cardiac Care

NCT00075088

Myocardial Infarction Chest Pain

COMPLETED PHASE3

Heart Monitoring Device After Acute Myocardium Infarction

NCT03494751

Acute Myocardial Infarction

UNKNOWN NA

Paced Electrocardiogram Requiring Fast Emergent Coronary Therapy (PERFECT) Study

NCT02765477

Acute Myocardial Infarction

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Infarction Heart Attack

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control (standard treatment) Group

Participants will receive routine cardiac treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

SmartHeart Device Group

In addition to routine cardiac treatment, participants will wear the SmartHeart device

Group Type EXPERIMENTAL

SmartHeart Device

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No