N/A
N=1,491
Improve SCA Bridge Study
Sudden Cardiac Arrest · Acute Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT03715790 ↗Enrolled (actual)
1,491
Serious AEs
12.1%
Results posted
Jan 2024
Primary outcome: Primary: Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management — 236; 934 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- EP referred group (Behavioral); Non-Referred group (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management |
236; 934 | — |
| SECONDARY Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI |
127 | — |
| SECONDARY Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI. |
18 | — |
| SECONDARY Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD |
162; 21; 42; 75; 40; 36 | — |
| SECONDARY Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality |
29 | — |
| SECONDARY Evolution of the Ejection Fraction Over the Immediate Period of Post MI |
39.8; 46.3 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03715790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.