Improve Sudden Cardiac Arrest Study

NCT02099721 | Completed Results

• 1 other identifier: Improve SCA
• Study Type: interventional
• Target: 4,222
• Locations: 16 countries
• Sites: 93

Brief Summary

The purpose of this study is to demonstrate that primary prevention patients with one or more additional risk factors (1.5 prevention criteria: syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent pre-ventricular contractions (PVCs), and low left ventricular ejection fraction (LVEF)) are at a similar risk of life-threatening ventricular arrhythmias (LTVA) when compared to secondary prevention patients, and would receive similar benefit from an implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy- defibrillator (CRT-D) implant.

Conditions

Sudden Cardiac Arrest; Ventricular Arrythmia

Keywords

Sudden Cardiac Arrest (SCA); Syncope; Non Sustained Ventricular Tachycardia (NSVT); Premature Ventricular Contractions (PVC); Left Ventricular Ejection Fraction (LVEF); Primary Prevention; Secondary Prevention; Antitachycardia pacing (ATP); shock; appropriate therapy

Outcome Measures

Primary Outcomes (1)

• Time to the First Occurrence of a Ventricular Arrhythmia

  Time to the first occurrence of an episode of true ventricular tachycardia or fibrillation 24 Month rates will be provided for the two groups used in the primary endpoint definition. However, the primary endpoint of hazard ratio is presented in Statistical Analysis 1 as a ratio between Groups A and C.

  Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month VT-VF rate (as compared in the Outcome Measure table between Groups A and C).

Secondary Outcomes (1)

• Mortality

  Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month mortality rate (as compared in the Outcome Measure table between Groups C and D).

Study Arms (6)

Group A: Secondary prevention patients- device implant

ACTIVE COMPARATOR

Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects receive an ICD/CRT-D implant.

Device: ICD or CRT-D Device

Group B: Secondary prevention patients - no device implant

NO INTERVENTION

Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects choose not to receive an ICD/CRT-D implant.

Group C: 1.5 Prevention patients - device implant

ACTIVE COMPARATOR

Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant.

Device: ICD or CRT-D Device

Group D: 1.5 prevention patients - no device implant

NO INTERVENTION

Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects choose not to receive an ICD/CRT-D implant.

Group E: Primary, non-1.5 patients - device implant

OTHER

Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group. These subjects receive an ICD/CRT-D implant.

Device: ICD or CRT-D Device

Group F: Primary, non-1.5 patients - no device

NO INTERVENTION

Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group. These subjects choose not to receive an ICD/CRT-D implant.

Interventions

ICD or CRT-D Device DEVICE

Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.

Group A: Secondary prevention patients- device implant; Group C: 1.5 Prevention patients - device implant; Group E: Primary, non-1.5 patients - device implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a Class I indication for implantation of an ICD according to the American College of Cardiology (ACC)/American Heart Association(AHA)/Heart Rhythm Society (HRS) or European Society of Cardiology (ESC) Guidelines
• Subject (or subject's legally authorized representative) is willing and able to sign and date the Patient Informed Consent Form.

You may not qualify if:

• Subject is ≤ 18 years of age
• Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader
• Subject has any contraindication for ICD/CRT-D

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (93)

Hospital Churruca

Buenos Aires, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

Hospital Universitario Fundación Favaloro

Buenos Aires, Argentina

Location

Instituto Cardiovascular de Buenos Aires (ICBA)

Buenos Aires, Argentina

Location

Republican Scientific and Practical Center "Cardiology"

Minsk, Belarus

Location

Real e Benemérita Associação Portuguesa de Beneficência

São Paulo, São Paulo, 01322, Brazil

Location

INCOR - Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, 5403-900, Brazil

Location

INCOR - Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, Brazil

Location

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

Xiamen Heart Center

Xiamen, Fujian, 361004, China

Location

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430022, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Wuxi Peoples Hospital

Wuxi, Jiangsu, 214023, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

First Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

The General Hospital of Shenyang Military Region

Shenyang, Liaoning, 110016, China

Location

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital, Sichuan University

Sichuan, Sichuan, 610041, China

Location

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

First People's Hospital of Yunnan Province

Kunming, Yunnan, 650032, China

Location

The First Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

Location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

Location

Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Location

The Second Xiangya Hospital of Central South University

Changsha, China

Location

The Second Affiliated Hospital of the Third Military Medical University

Chongqing, China

Location

Fujian Provincial Hospital

Fuzhou, 350001, China

Location

Sun Yat-Sen Memorial Hospital Sun Yat-Sen University

Guangzhou, 510000, China

Location

The First Affiliated Hospital of Sun Yat-Sen Medical University

Guangzhou, 510000, China

Location

Guizhou Province People's Hospital

Guiyang, China

Location

The First Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, 310003, China

Location

The Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, China

Location

Zhejiang Greentown Cardiovascular Hospital

Hangzhou, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, 150001, China

Location

Jinhua Municipal Central Hospital

Jinhua, China

Location

Jiangsu Province People's Hospital

Nanjing, 210029, China

Location

Ruijin Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

Location

Renji Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, 200127, China

Location

Xinhua Hospital Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Zhongshan Hospital Fudan University

Shanghai, China

Location

Shenzhen Sun Yat-sen Cardiovascular Hospital

Shenzhen, 518001, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, China

Location

The First Affiliated Hospital Of Xi'an Jiaotong University

Xi'an, 710061, China

Location

Fundacion Cardioinfantil

Bogotá, Colombia

Location

Wadi El-Neel Hospital

Cairo, Egypt

Location

Care Hospital

Hyderabad, Andhra Pra, India

Location

Medanta- The Medicity

Gurgaon, Haryana, India

Location

Ruby Hall Clinic

Pune, Maharashtr, India

Location

King George's Medical University

Lucknow, Uttar Prad, 226003, India

Location

BM Birla Heart Research Centre

Kolkata, West Bengal, 700027, India

Location

Care Institute of Medical Sciences (CIMS)

Ahmedabad, India

Location

Post Graduate Institute of Medical Education & Research

Chandigarh, 160012, India

Location

Lisie Hospital

Kochi, 682018, India

Location

B.M. Birla Heart Reserch Centre

Kolkata, 700027, India

Location

BM Birla Heart Research CentreB

Kolkata, 700027, India

Location

All India Institute of Medical Sciences

New Delhi, India

Location

Govind Ballabh Pant Hospital

New Delhi, India

Location

Krishna Institute of Medical Sciences (KIMS)

Secunderabad, India

Location

Institut Jantung Negara - National Heart Institute

Kuala Lumpur, Malaysia

Location

Universiti Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Hospital Angeles Lomas

León, Guanajuato, 37150, Mexico

Location

Hospital Angeles Lomas

Huixquilucan de Degollado, 52763, Mexico

Location

Hospital Angeles Leon

León, Mexico

Location

Hospital General de Puebla

Puebla City, Mexico

Location

Russian Scientific Center of Surgery by B.V. Petrovkiy, RAMN

Moscow, 119991, Russia

Location

Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN

Moscow, Russia

Location

Novosibirsk Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

Scientific Research Institute of Cardiology

Tomsk, 634012, Russia

Location

Tyumen Regional Clinical Hospital

Tyumen, 625023, Russia

Location

Tyumen Cardiology Center

Tyumen, 625026, Russia

Location

Tyumen Cardiology Center

Tyumen, Russia

Location

Tyumen Regional Clinical Hospital

Tyumen, Russia

Location

Changi General Hospital

Singapore, Singapore

Location

National Heart Centre Singapore

Singapore, Singapore

Location

Groote Schuur Hospital

Cape Town, South Africa

Location

Sejong Hospital

Bucheon-si, South Korea

Location

Dong-A University Hospital

Busan, 602-812, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

The Catholic University of Korea Seoul Saint Mary's Hospital

Seoul, South Korea

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Taiwan University Hospital Hsin Chu Branch

Taipei, 10002, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Military Hospital

Montfleury, Tunisia

Location

Dubai Hospital

Dubai, United Arab Emirates

Location

Related Publications (6)

• Zhao S, Ching CK, Huang D, Liu YB, Rodriguez-Guerrero DA, Hussin A, Kim YH, Van Dorn B, Zhou X, Singh B, Zhang S; Improve SCA Investigators. Regional disparities and risk factors of mortality among patients at high risk of sudden cardiac death in emerging countries: a nonrandomized controlled trial. BMC Med. 2024 Mar 22;22(1):130. doi: 10.1186/s12916-024-03310-5.

  PMID: 38519982 DERIVED

• Singh B, Hsieh YC, Liu YB, Lin KH, Joung B, Rodriguez DA, Chasnoits AR, Huang D, Zhang S, O'Brien JE, Lexcen DR, Cerkvenik J, Van Dorn B, Ching CK. Cardioverter-defibrillator reduces mortality risk in eligible ischemic and non-ischemic cardiomyopathy patients: Sub-analysis of the multi-center Improve SCA study. Indian Heart J. 2023 Mar-Apr;75(2):115-121. doi: 10.1016/j.ihj.2023.01.010. Epub 2023 Feb 2.

  PMID: 36736459 DERIVED

• Ching CK, Hsieh YC, Liu YB, Rodriguez DA, Kim YH, Joung B, Singh B, Huang D, Hussin A, Chasnoits AR, O'Brien JE, Cerkvenik J, Lexcen D, Van Dorn B, Zhang S. The mortality analysis of primary prevention patients receiving a cardiac resynchronization defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD) according to guideline indications in the improve SCA study. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2285-2294. doi: 10.1111/jce.15149. Epub 2021 Jul 9.

  PMID: 34216069 DERIVED

• Zhang S, Ching CK, Huang D, Liu YB, Rodriguez-Guerrero DA, Hussin A, Kim YH, Chasnoits AR, Cerkvenik J, Lexcen DR, Muckala K, Brown ML, Cheng A, Singh B; Improve SCA Investigators. Utilization of implantable cardioverter-defibrillators for the prevention of sudden cardiac death in emerging countries: Improve SCA clinical trial. Heart Rhythm. 2020 Mar;17(3):468-475. doi: 10.1016/j.hrthm.2019.09.023. Epub 2019 Sep 24.

  PMID: 31561030 DERIVED

• Singh B, Zhang S, Ching CK, Huang D, Liu YB, Rodriguez DA, Hussin A, Kim YH, Chasnoits AR, Cerkvenik J, Muckala KA, Cheng A. Improving the utilization of implantable cardioverter defibrillators for sudden cardiac arrest prevention (Improve SCA) in developing countries: Clinical characteristics and reasons for implantation refusal. Pacing Clin Electrophysiol. 2018 Dec;41(12):1619-1626. doi: 10.1111/pace.13526. Epub 2018 Oct 31.

  PMID: 30320410 DERIVED

• Zhang S, Singh B, Rodriguez DA, Chasnoits AR, Hussin A, Ching CK, Huang D, Liu YB, Cerkvenik J, Willey S, Kim YH. Improve the prevention of sudden cardiac arrest in emerging countries: the Improve SCA clinical study design. Europace. 2015 Nov;17(11):1720-6. doi: 10.1093/europace/euv103. Epub 2015 Jun 1.

  PMID: 26037794 DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac; Syncope; Ventricular Premature Complexes; Shock

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Cardiac Complexes, Premature; Arrhythmias, Cardiac; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Limitations and Caveats

The IMPROVE SCA trial was an non-blinded post-market trial that was not randomized. Thus baseline variables will differ across the treatment groups. Covariate adjustments were made in the analyses as a result.

Results Point of Contact

• Title: Katy Muckala, Sr. Clinical Research Specialist
• Organization: Medtronic CRHF

katy.a.muckala@medtronic.com

(763) 526-1767

Study Officials

• Shu Zhang

  Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: March 31, 2014
• Study Start: March 1, 2014
• Primary Completion: July 15, 2018
• Study Completion: September 5, 2018
• Last Updated: October 28, 2020
• Results First Posted: October 28, 2020

Record last verified: 2020-10

Locations

EG (1); ZA (1); TW (6); TU (1); BR (3); BE (1); AR (4); CO (1); RU (8); SG (2); MY (2); KR (9); IN (13); AE (1); CN (36); ME (4)