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).
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.
Study Type
OBSERVATIONAL
Enrollment
1,491
Referred for sudden cardiac death (SCD) risk stratification and management
Not referred for sudden cardiac death (SCD) risk stratification and management.
Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management
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.
Time frame: 3-months post-MI to 12-months post-MI
Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 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.
Time frame: 3-months post-MI to 12-months post-MI
Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 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.
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National Heart Foundation Hospital and Research Institute
Dhaka, Bangladesh
Gleneagles Jerudong Park Medical Centre
Brunei, Brunei
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
...and 42 more locations
Time frame: 3-months post-MI to 12-months post-MI
Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD
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.
Time frame: 3-months post-MI to 12-months post-MI
Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality
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.
Time frame: Enrollment to 12-months post-MI
Evolution of the Ejection Fraction 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 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.
Time frame: Enrollment to 3-months post-MI