Improve SCA Bridge Study

Study Overview
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Brief Summary
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The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of post-acute myocardial infarction (MI) patients as a result of standard assessments of left ventricular ejection fraction (LVEF) in the acute phase (≤14 days post- acute MI) and chronic phase (≥40-90 days post-acute MI).

Detailed Description
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To determine how many patients are referred for sudden cardiac death (SCD) risk stratification and management, indicated for implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy- defibrillator (CRT-D) implant, and how many receive such devices within 12 months of experiencing an MI.

Official Title
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Improve Sudden Cardiac Arrest (SCA) Bridge Study

Conditions
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Sudden Cardiac Arrest, Acute Myocardial Infarction

Intervention / Treatment
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* Behavioral: EP referred group
* Behavioral: Non-Referred group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and above (or meet age requirements per local law) Patients who have an acute Myocardial Infarction (MI) (STEMI or Non-STEMI) ≤ 30 days of study enrollment and have a LVEF <50% measurement ≤ 14 days post-acute MI Willing and able to give valid Informed Consent Exclusion Criteria: Patient has previously received or currently implanted with an ICD or CRT-D Patient has any contraindication for ICD/CRT-D Patient has a life expectancy of less than 12 months Patient who has had an EP referral within the last 12 months Any exclusion criteria required by local law (e.g. pregnancy, breast feeding etc.) Patient is unable (e.g. mental disorder) or unwilling to be compliant with the responsibilities as specified in the informed consent form. Patient is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EP Referred Group<br>Subjects with EF ≤ 40% or meeting one of the referral criteria | Behavioral: EP referred group<br>* Referred for sudden cardiac death (SCD) risk stratification and management<br>|
| Non-Referred Group<br>Subjects with 40%< EF <50%. | Behavioral: Non-Referred group<br>* Not referred for sudden cardiac death (SCD) risk stratification and management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of post-acute MI patients who are referred for sudden cardiac death risk (SCD) stratification and management | The endpoint will be defined as the clinician's determination to refer the subject for SCD risk stratification and management | 3-months post-MI to 12-months post-MI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of post-acute MI patients who are known to be indicated for an ICD/CRT-D within 12 months post-MI | The endpoint will be defined as whether a subject was indicated for an ICD/CRT-D device during follow-up. | 3-months post-MI to 12-months post-MI | 
| Proportion of post-acute MI patients who receive an ICD/CRT-D within 12 months post-MI. | The endpoint will be defined as whether a subject received an ICD/CRT-D device during follow-up. | 3-months post-MI to 12-months post-MI | 
| Summarize the referral and implant refusal rationale | The outcome measure will be the proportion of patients with ICD indication, who were not referred, refused referral or refused implant. The denominator will count all patients with at least one of the below: a reduced ejection fraction, as measured by the Left Ventricular Ejection Fraction (LVEF) being lower or equal than 40%. ventricular arrhythmia, AV block, new onset bundle branch block, or conduction abnormalities as measured by ECGs. unexplained syncope, clinically significant palpitations or symptomatic bradycardia as assessed by the physician. The numerator will count the patients included in the denominator who were not referred, refused referral or refused implant of an ICD/CRT-D. | 3-months post-MI to 12-months post-MI | 
| Proportion of post-acute MI patients who experience cardiovascular mortality | The endpoint will be defined as cardiovascular mortality. | Enrollment to 12-months post-MI | 
| Determine how the ejection fraction evolves over the immediate period of post MI | The Left Ventricular Ejection Fraction (LVEF) will be measured acutely post MI (≤14 days after MI onset) and chronically (40-90 days). The endpoint will be the change between the acute and the chronic measurement. | Enrollment to 12-months post-MI |