Clinical trial NCT03715790: Improve SCA Bridge Study
Official title: Improve Sudden Cardiac Arrest (SCA) Bridge Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sudden Cardiac Arrest
Acute Myocardial Infarction
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2018-10-23
Enrollment: 1491
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have an acute Myocardial Infarction (MI) (STEMI or Non-STEMI).

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 and above (or meet age requirements per local law)
* 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 previously received or currently implanted with an ICD or CRT-D
* 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
* Any exclusion criteria required by local law (e.g. pregnancy, breast feeding etc.)
* 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

Primary outcomes:
measure: Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management
timeFrame: 3-months post-MI to 12-months post-MI
Secondary outcomes:
measure: Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI
timeFrame: 3-months post-MI to 12-months post-MI
measure: Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI.
timeFrame: 3-months post-MI to 12-months post-MI
measure: Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD
timeFrame: 3-months post-MI to 12-months post-MI
measure: Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality
timeFrame: Enrollment to 12-months post-MI
measure: Evolution of the Ejection Fraction Over the Immediate Period of Post MI
timeFrame: Enrollment to 3-months post-MI
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: National Heart Foundation Hospital and Research Institute
city: Brunei
country: Brunei Darussalam
facility: Gleneagles Jerudong Park Medical Centre
city: Beijing
country: China
facility: Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
city: Beijing
country: China
facility: Peking University First Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Chendu
country: China
facility: West China Hospital of Sichuan University
city: Guangzhou
country: China
facility: Sun Yat-SEN Memorial hospital, Sun Yat-sen University
city: Guizhou
country: China
facility: Guizhou Provincial People's Hospital
city: Hangzhou
country: China
facility: Hangzhou First People Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital School of Medicine Zhejiang University
city: Lanzhou
country: China
facility: The first Hospital of Lanzhou Hospital
city: Nanjing
country: China
facility: Nanjing First Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Sichuan
country: China
facility: Sichuan Provincial People's Hospital
city: Wuhan
country: China
facility: Wuhan Asia heart hospital
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital
city: Xinjiang
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
city: Alexandria
country: Egypt
facility: International Cardic Center
city: Chennai
country: India
facility: The Madras Medical Mission
city: Jaipur
country: India
facility: Eternal Hospital
city: Mangalore
country: India
facility: Kasturba Medical College Hospital
city: New Delhi
country: India
facility: Batra Hospital and Medical Research Centre (BHMRC)
city: New Delhi
country: India
facility: Fortis Escorts Heart Institute
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita
city: Jakarta
country: Indonesia
facility: Rumah Sakit Cipto Mangunkusumo
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Sejong General Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Kajang
country: Malaysia
facility: Hospital Serdang
city: Kota Kinabalu
country: Malaysia
facility: Queen Elizabeth II Hospital
city: Kota Samarahan
country: Malaysia
facility: Sarawak Heart Centre
city: Karachi
country: Pakistan
facility: National Institute of Cardiovascular Diseases
city: Manila
country: Philippines
facility: Chinese General Hospital and Medical Center
city: Jeddah
country: Saudi Arabia
facility: King Fahad Armed Forces Hospital
city: Riyadh
country: Saudi Arabia
facility: Prince Sultan Cardiac Center
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Cape Town
country: South Africa
facility: Mediclinic Panorama
city: Pretoria
country: South Africa
facility: Netcare Unitas Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital of CGMF
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Montfleury
country: Tunisia
facility: The Military Hospital of Tunis
Study officials:
affiliation: Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
name: Shu Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.