Study Results
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View full resultsBasic Information
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COMPLETED
1491 participants
OBSERVATIONAL
2018-11-02
2021-05-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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EP Referred Group
Subjects with EF ≤ 40% or meeting one of the referral criteria
EP referred group
Referred for sudden cardiac death (SCD) risk stratification and management
Non-Referred Group
Subjects with 40%\< EF \<50%.
Non-Referred group
Not referred for sudden cardiac death (SCD) risk stratification and management.
Interventions
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EP referred group
Referred for sudden cardiac death (SCD) risk stratification and management
Non-Referred group
Not referred for sudden cardiac death (SCD) risk stratification and management.
Eligibility Criteria
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Inclusion Criteria
* 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 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Shu Zhang
Role: PRINCIPAL_INVESTIGATOR
Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Locations
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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
The first Hospital of Lanzhou Hospital
Lanzhou, , China
Nanjing First Hospital
Nanjing, , China
Shanghai Chest Hospital
Shanghai, , China
Sichuan Provincial People's Hospital
Sichuan, , China
Wuhan Asia heart hospital
Wuhan, , China
Xiamen Cardiovascular Hospital
Xiamen, , China
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, , China
International Cardic Center
Alexandria, , Egypt
The Madras Medical Mission
Chennai, , India
Eternal Hospital
Jaipur, , India
Kasturba Medical College Hospital
Mangalore, , India
Batra Hospital and Medical Research Centre (BHMRC)
New Delhi, , India
Fortis Escorts Heart Institute
New Delhi, , India
National Cardiovascular Center Harapan Kita
Jakarta, , Indonesia
Rumah Sakit Cipto Mangunkusumo
Jakarta, , Indonesia
Hospital Serdang
Kajang, , Malaysia
Queen Elizabeth II Hospital
Kota Kinabalu, , Malaysia
Sarawak Heart Centre
Kota Samarahan, , Malaysia
National Institute of Cardiovascular Diseases
Karachi, , Pakistan
Chinese General Hospital and Medical Center
Manila, , Philippines
King Fahad Armed Forces Hospital
Jeddah, , Saudi Arabia
Prince Sultan Cardiac Center
Riyadh, , Saudi Arabia
Changi General Hospital
Singapore, , Singapore
Mediclinic Panorama
Cape Town, , South Africa
Netcare Unitas Hospital
Pretoria, , South Africa
Chonnam National University Hospital
Gwangju, , South Korea
Sejong General Hospital
Gyeonggi-do, , South Korea
Pusan National University Yangsan Hospital
Pusan, , South Korea
Asan Medical Center
Seoul, , South Korea
Keimyung University Dongsan Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Bundang Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kaohsiung Chang Gung Memorial Hospital of CGMF
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
The Military Hospital of Tunis
Montfleury, , Tunisia
Countries
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References
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Chew DS, Wilton SB, Kavanagh K, Southern DA, Tan-Mesiatowsky LE, Exner DV; APPROACH Investigators. Left ventricular ejection fraction reassessment post-myocardial infarction: Current clinical practice and determinants of adverse remodeling. Am Heart J. 2018 Apr;198:91-96. doi: 10.1016/j.ahj.2017.11.014. Epub 2017 Dec 5.
Adabag AS, Therneau TM, Gersh BJ, Weston SA, Roger VL. Sudden death after myocardial infarction. JAMA. 2008 Nov 5;300(17):2022-9. doi: 10.1001/jama.2008.553.
Chia YMF, Teng TK, Tan ESJ, Tay WT, Richards AM, Chin CWL, Shimizu W, Park SW, Hung CL, Ling LH, Ngarmukos T, Omar R, Siswanto BB, Narasimhan C, Reyes EB, Yu CM, Anand I, MacDonald MR, Yap J, Zhang S, Finkelstein EA, Lam CSP. Disparity Between Indications for and Utilization of Implantable Cardioverter Defibrillators in Asian Patients With Heart Failure. Circ Cardiovasc Qual Outcomes. 2017 Nov;10(11):e003651. doi: 10.1161/CIRCOUTCOMES.116.003651.
O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the American College of Emergency Physicians and Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2013 Jul 1;82(1):E1-27. doi: 10.1002/ccd.24776. Epub 2013 Jan 8. No abstract available.
Zhang S, Chen WJ, Sankardas MA, Ahmed WH, Liew HB, Gwon HC, Nesa Malik FT, Tang B, Haggui A, Oh IY, Ong TK, Cheng CI, Liu X, Seth A, Choi YJ, Qamar N, Rungpradubvong V, Wang CC, Jeon J, Wong G, Lemme F, Van Dorn B, Lexcen D, Huang D; Improve Sudden Cardiac Arrest Bridge Investigators. Improve the Prevention of Sudden Cardiac Arrest in Patients With Post-Acute Myocardial Infarction. JACC Asia. 2022 Sep 20;2(5):559-571. doi: 10.1016/j.jacasi.2022.06.006. eCollection 2022 Oct.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MDT18019
Identifier Type: -
Identifier Source: org_study_id
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