Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 1720-1726 |
| Number of pages | 7 |
| Journal | Europace |
| Volume | 17 |
| Issue number | 11 |
| DOIs | |
| Publication status | Published - 2015 Sep 28 |
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Keywords
- LVEF
- NSVT
- Primary prevention
- PVCs
- SCA
- Secondary prevention
- Syncope
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
- Physiology (medical)
Cite this
Improve the prevention of sudden cardiac arrest in emerging countries : The Improve SCA clinical study design. / Zhang, Shu; Singh, Balbir; Rodriguez, Diego A.; Chasnoits, Alexandr Robertovich; Hussin, Azlan; Ching, Chi Keong; Huang, Dejia; Liu, Yen Bin; Cerkvenik, Jeffrey; Willey, Sarah; Kim, Young Hoon.
In: Europace, Vol. 17, No. 11, 28.09.2015, p. 1720-1726.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Improve the prevention of sudden cardiac arrest in emerging countries
T2 - The Improve SCA clinical study design
AU - Zhang, Shu
AU - Singh, Balbir
AU - Rodriguez, Diego A.
AU - Chasnoits, Alexandr Robertovich
AU - Hussin, Azlan
AU - Ching, Chi Keong
AU - Huang, Dejia
AU - Liu, Yen Bin
AU - Cerkvenik, Jeffrey
AU - Willey, Sarah
AU - Kim, Young Hoon
PY - 2015/9/28
Y1 - 2015/9/28
N2 - 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.
AB - 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.
KW - LVEF
KW - NSVT
KW - Primary prevention
KW - PVCs
KW - SCA
KW - Secondary prevention
KW - Syncope
UR - http://www.scopus.com/inward/record.url?scp=84950311843&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84950311843&partnerID=8YFLogxK
U2 - 10.1093/europace/euv103
DO - 10.1093/europace/euv103
M3 - Article
C2 - 26037794
AN - SCOPUS:84950311843
VL - 17
SP - 1720
EP - 1726
JO - Europace
JF - Europace
SN - 1099-5129
IS - 11
ER -