Improve SCA Bridge Study

Improve Sudden Cardiac Arrest (SCA) Bridge Study

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).

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction; Sudden Cardiac Arrest
• Intervention / Treatment: Behavioral: EP referred group; Behavioral: Non-Referred group

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.

• Study Type: Observational
• Enrollment (Actual): 1491

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • National Heart Foundation Hospital and Research Institute
• Brunei Darussalam
  • Brunei, Brunei Darussalam
    • Gleneagles Jerudong Park Medical Centre
• China
  • Beijing, China
    • Peking University first hospital
  • Beijing, China
    • Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
  • Changsha, China
    • The second Xiangya Hospital of Central South University
  • Chendu, China
    • West China Hospital of Sichuan University
  • Guangzhou, China
    • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • Guizhou, China
    • Guizhou Provincial People's Hospital
  • Hangzhou, China
    • Hangzhou First People Hospital
  • Hangzhou, China
    • Sir Run Run Shaw Hospital School of Medicine Zhejiang University
  • Lanzhou, China
    • The first Hospital of Lanzhou Hospital
  • Nanjing, China
    • Nanjing First Hospital
  • Shanghai, China
    • Shanghai Chest Hospital
  • Sichuan, China
    • Sichuan Provincial People's Hospital
  • Wuhan, China
    • Wuhan Asia Heart Hospital
  • Xiamen, China
    • Xiamen Cardiovascular Hospital
  • Xinjiang, China
    • The first affiliated hospital of Xinjiang medical university
• Egypt
  • Alexandria, Egypt
    • International Cardic Center
• India
  • Chennai, India
    • The Madras Medical Mission
  • Jaipur, India
    • Eternal Hospital
  • Mangalore, India
    • Kasturba Medical College Hospital
  • New Delhi, India
    • Fortis Escorts Heart Institute
  • New Delhi, India
    • Batra Hospital and Medical Research Centre (BHMRC)
• Indonesia
  • Jakarta, Indonesia
    • Rumah Sakit Cipto Mangunkusumo
  • Jakarta, Indonesia
    • National Cardiovascular Center Harapan Kita
• Korea, Republic of
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Gyeonggi-do, Korea, Republic of
    • Sejong General Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Yangsan Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Keimyung University Dongsan Medical Center
• Malaysia
  • Kajang, Malaysia
    • Hospital Serdang
  • Kota Kinabalu, Malaysia
    • Queen Elizabeth II Hospital
  • Kota Samarahan, Malaysia
    • Sarawak Heart Centre
• Pakistan
  • Karachi, Pakistan
    • National Institute of CardioVascular Diseases
• Philippines
  • Manila, Philippines
    • Chinese General Hospital and Medical Center
• Saudi Arabia
  • Jeddah, Saudi Arabia
    • King Fahad Armed Forces Hospital
  • Riyadh, Saudi Arabia
    • Prince Sultan Cardiac Center
• Singapore
  • Singapore, Singapore
    • Changi General Hospital
• South Africa
  • Cape Town, South Africa
    • Mediclinic Panorama
  • Pretoria, South Africa
    • Netcare Unitas Hospital
• Taiwan
  • Kaohsiung, Taiwan
    • Kaohsiung Chang Gung Memorial Hospital of CGMF
  • New Taipei City, Taiwan
    • Far Eastern Memorial Hospital
  • Taichung, Taiwan
    • China Medical University Hospital
  • Taipei, Taiwan
    • Mackay Memorial Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taoyuan, Taiwan
    • Linkou Chang Gung Memorial Hospital
• Thailand
  • Bangkok, Thailand
    • King Chulalongkorn Memorial Hospital
• Tunisia
  • Montfleury, Tunisia
    • The Military Hospital of Tunis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who have an acute Myocardial Infarction (MI) (STEMI or Non-STEMI).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EP Referred Group; Subjects with EF ≤ 40% or meeting one of the referral criteria	Behavioral: EP referred group; Referred for sudden cardiac death (SCD) risk stratification and management
Non-Referred Group; Subjects with 40%< EF <50%.	Behavioral: Non-Referred group; Not referred for sudden cardiac death (SCD) risk stratification and management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management	The numerator for this endpoint will be defined as the number of patients who met the clinician's determination to refer the subject for SCD risk stratification and management at any of the three follow-up visits. The denominator for this endpoint is the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this one arm. No hypotheses were tested for this endpoint.	3-months post-MI to 12-months post-MI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI	The numerator for this endpoint will be the number of subjects who were indicated for an ICD/CRT-D device during any of the three follow-up visits. The denominator will be the number of subjects who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the "referred" and "not referred" groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint.	3-months post-MI to 12-months post-MI
Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI.	The numerator for this endpoint will be the number of subjects who received an ICD/CRT-D device during any of the three follow-up visits. The denominator for this endpoint will be the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the "referred" and "not referred" groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint.	3-months post-MI to 12-months post-MI
Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD	The outcome measure will be the percentage of patients with ICD indication, who were not referred, refused referral or refused implant. The denominator will count all patients with at least one of the below: a reduced ejection fraction, as measured by the Left Ventricular Ejection Fraction (LVEF) being lower or equal than 40%.>; ventricular arrhythmia, AV block, new onset bundle branch block, or conduction abnormalities as measured by ECGs.>; unexplained syncope, clinically significant palpitations or symptomatic bradycardia as assessed by the physician.> The numerator will count the patients included in the denominator who were not referred, refused referral or refused implant of an ICD/CRT-D.While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the referral process results in the single arm of enrolled patients, with analysis performed within this arm.No hypotheses were tested for this endpoint.	3-months post-MI to 12-months post-MI
Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality	The numerator for this endpoint will be the number of patients who experience cardiovascular mortality. The denominator will be the number of patients enrolled in the study. No hypotheses were tested for this endpoint.	Enrollment to 12-months post-MI
Evolution of the Ejection Fraction Over the Immediate Period of Post MI	The Left Ventricular Ejection Fraction (LVEF) will be measured acutely post MI (≤14 days after MI onset) and chronically (40-90 days). The acute measurement will occur over all 1491 subjects assessed at baseline, while the chronic assessment will be measured over the 1046 subjects with a 3-month LVEF assessment. This outcome will compare the average LVEF, by percent, between these two phases. No hypotheses were tested for this endpoint.	Enrollment to 3-months post-MI

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Shu Zhang, Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2018
• Primary Completion (Actual): April 16, 2021
• Study Completion (Actual): May 27, 2021

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: October 19, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Death, Sudden; Death; Myocardial Infarction; Infarction; Heart Arrest; Death, Sudden, Cardiac
• Other Study ID Numbers: MDT18019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No