Myocardial Infarction, COmbined-device, Recovery Enhancement Study (MiCORE)

Johns Hopkins University

Status: Completed

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Myocardial Infarction; Acute Myocardial Infarction

Treatments: Device: Corrie Health Digital Platform

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03760796

IRB00099938

Details and patient eligibility

About

Unplanned readmissions after hospitalization for acute myocardial infarction (AMI) are among the leading causes of preventable morbidity, mortality, and healthcare costs. Digital health interventions (DHI) could be an effective tool in promoting self-management, adherence to guideline directed therapy, and cardiovascular risk reduction.

A DHI developed at Johns Hopkins-the Corrie Health Digital Platform-includes the first cardiology Apple CareKit smartphone application, paired with an Apple Watch and iHealth Bluetooth-enabled blood pressure monitor. Corrie targets: (1) self-management of cardiac medications, (2) self-tracking of vital signs, (3) education about cardiovascular disease through articles and animated videos, and (4) care coordination that includes cardiac rehabilitation and outpatient follow-up appointments.

In this prospective study, STEMI or type 1 NSTEMI patients are being enrolled to use the Corrie Health Digital Platform beginning early during participants' hospital stay. Enrollment sites include Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Massachusetts General Hospital, and Reading Hospital. The primary objective is to compare time to first readmission within 30 days post-discharge among patients with the Corrie Health Digital Platform to patients in the historical standard of care comparison group.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Corrie Health Digital Platform group

Inclusion Criteria:

• Admitted for acute myocardial infarction (STEMI or Type 1 NSTEMI)
• 18 years or older
• English-speaking
• Own any type of smartphone

Exclusion Criteria:

• Visual, hearing, or motor impairment which precludes the use of the intervention
• Inability to participate due to severity of illness (e.g., intubated and on sedation in the setting of cardiogenic shock). If patients are deemed clinically unstable and unable to participate at the time of initial screening, the research team member returns at a later date to determine whether this status has changed.

Historical Standard of Care Comparison group

Inclusion Criteria:

• Admitted for acute myocardial infarction (STEMI or NSTEMI)
• 18 years or older
• English-speaking

Exclusion Criteria:

• None

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Corrie Health Digital Platform group

Experimental group

Description:

Receives the Corrie Health intervention plus the standard of care

Treatment:

Device: Corrie Health Digital Platform