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Improve the prevention of sudden cardiac arrest in emerging countries: the Improve SCA clinical study design
Shu Zhang1, Balbir Singh2, Diego A Rodriguez3
1State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 North Lishi Road, Beijing 100037, China zsfuwai@vip.163.com.
Insights
High-risk primary prevention patients may benefit from implantable cardioverter defibrillators (ICDs) similarly to secondary prevention patients. This study evaluates ICD therapy for sudden cardiac arrest (SCA) prevention in underutilized regions.
Area of Science:
- Cardiology
- Electrophysiology
- Preventive Medicine
Background:
- Sudden cardiac arrest (SCA) remains a significant cause of mortality.
- Implantable cardioverter defibrillators (ICDs) are established for secondary prevention (SP) of life-threatening ventricular arrhythmias.
- Primary prevention (PP) strategies for SCA are underutilized in many regions.
Purpose of the Study:
- To assess if primary prevention (PP) patients with specific risk factors face similar risks of life-threatening ventricular arrhythmias as secondary prevention (SP) patients.
- To evaluate the potential benefit of implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) in high-risk PP patients.
- To inform clinical decision-making and guideline expansion for PP of SCA, particularly in under-resourced geographical areas.
Main Methods:
- The Improve SCA study enrolled 4800 ICD-eligible patients across Asia, Latin America, Eastern Europe, the Middle East, and Africa.
- Patients were categorized as SP or PP, with PP patients having one or more risk factors (syncope, non-sustained ventricular tachycardia, frequent premature ventricular contractions, low LVEF) classified as '1.5' patients.
- The primary endpoint compared appropriate ICD therapy rates between SP and '1.5' patients; the secondary endpoint compared mortality between implanted and non-implanted '1.5' patients.
Main Results:
- The study is designed to compare the rates of appropriate ICD therapy between SP and '1.5' PP patients.
- It will also analyze mortality differences between '1.5' patients who received an ICD/CRT-D and those who did not.
- Results are anticipated to provide evidence on the efficacy of ICDs in a high-risk PP population.
Conclusions:
- The Improve SCA study investigates a high-risk PP patient subset potentially comparable to SP patients in arrhythmia risk.
- Findings may guide clinicians in identifying and referring high-risk PP patients for ICDs.
- Results could support expanded guidelines for PP of SCA using ICDs and empower patient decisions regarding defibrillation therapy.
Aims:
This study aims to demonstrate that primary prevention (PP) patients with one or more additional risk factors are at a similar risk of life-threatening ventricular arrhythmias when compared with secondary prevention (SP) patients, and would receive similar benefit from an implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy-defibrillator (CRT-D) implant. The study evaluates the benefits of therapy for high-risk patients in countries where defibrillation therapy for PP of SCA is underutilized.
Methods:
Enrolment will consist of 4800 ICD-eligible patients from Asia, Latin America, Eastern Europe, the Middle East, and Africa. Upon enrolment, patients will be categorized as SP or PP. Primary prevention patients will be assessed for additional risk factors: syncope/pre-syncope, non-sustained ventricular tachycardia, frequent premature ventricular contractions, and low left ventricular ejection fraction. Those PP patients with one or more risk factors will be categorized as '1.5' patients. Implant of an ICD/CRT-D will be left to the patient and/or physician's discretion. The primary endpoint will compare the appropriate ICD therapy rate between SP and 1.5 patients. The secondary endpoint compares mortality between 1.5 implanted and non-implanted patients.
Conclusion:
The Improve SCA study will investigate a subset of PP patients, believed to be at similar risk of life-threatening ventricular arrhythmias as SP patients. Results may help clinicians identify and refer the highest risk PP patients for ICDs, help local societies expand guidelines to include PP of SCA utilizing ICDs, and provide additional geographical-relevant evidence to allow patients to make an informed decision whether to receive an ICD.
Trial Registration:
NCT02099721.
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