Improve SCA Bridge Study

Completed

Conditions: Sudden Cardiac Arrest
Acute Myocardial Infarction

Interventions: Behavioral: EP referred group
Behavioral: Non-Referred group

Registration Number: NCT03715790

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief 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).

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1491

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EP Referred Group	EP referred group	Subjects with EF ≤ 40% or meeting one of the referral criteria
Non-Referred Group	Non-Referred group	Subjects with 40%\< EF \<50%.

Primary Outcome Measures

Name	Time	Method
Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management	3-months post-MI to 12-months post-MI	The numerator for this endpoint will be defined as the number of patients who met the clinician's determination to refer the subject for SCD risk stratification and management at any of the three follow-up visits. The denominator for this endpoint is the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this one arm. No hypotheses were tested for this endpoint.

Secondary Outcome Measures

Name	Time	Method
Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI.	3-months post-MI to 12-months post-MI	The numerator for this endpoint will be the number of subjects who received an ICD/CRT-D device during any of the three follow-up visits. The denominator for this endpoint will be the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the "referred" and "not referred" groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint.
Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI	3-months post-MI to 12-months post-MI	The numerator for this endpoint will be the number of subjects who were indicated for an ICD/CRT-D device during any of the three follow-up visits. The denominator will be the number of subjects who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the "referred" and "not referred" groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint.
Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD	3-months post-MI to 12-months post-MI	The outcome measure will be the percentage 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: 1. a reduced ejection fraction, as measured by the Left Ventricular Ejection Fraction (LVEF) being lower or equal than 40%. \> 2. ventricular arrhythmia, AV block, new onset bundle branch block, or conduction abnormalities as measured by ECGs. \> 3. 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. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the referral process results in the single arm of enrolled patients, with analysis performed within this arm. No hypotheses were tested for this endpoint.
Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality	Enrollment to 12-months post-MI	The numerator for this endpoint will be the number of patients who experience cardiovascular mortality. The denominator will be the number of patients enrolled in the study. No hypotheses were tested for this endpoint.
Evolution of the Ejection Fraction Over the Immediate Period of Post MI	Enrollment to 3-months 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 acute measurement will occur over all 1491 subjects assessed at baseline, while the chronic assessment will be measured over the 1046 subjects with a 3-month LVEF assessment. This outcome will compare the average LVEF, by percent, between these two phases. No hypotheses were tested for this endpoint.

Trial Locations

Locations (52): National Heart Foundation Hospital and Research Institute
🇧🇩
Dhaka, Bangladesh
Gleneagles Jerudong Park Medical Centre
🇧🇳
Brunei, Brunei Darussalam
Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
🇨🇳
Beijing, China
Peking University First Hospital
🇨🇳
Beijing, China
The Second Xiangya Hospital of Central South University
🇨🇳
Changsha, China
West China Hospital of Sichuan University
🇨🇳
Chendu, China
Sun Yat-SEN Memorial hospital, Sun Yat-sen University
🇨🇳
Guangzhou, China
Guizhou Provincial People's Hospital
🇨🇳
Guizhou, China
Hangzhou First People Hospital
🇨🇳
Hangzhou, China
Sir Run Run Shaw Hospital School of Medicine Zhejiang University
🇨🇳
Hangzhou, China
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National Heart Foundation Hospital and Research Institute
🇧🇩Dhaka, Bangladesh