Improve SCA Bridge Study

Acute Myocardial Infarction Clinical Trial

Official title:

Improve Sudden Cardiac Arrest (SCA) Bridge Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03715790
• Other study ID #: MDT18019
• Status: Completed
• Start date: November 2, 2018
• Est. completion date: May 27, 2021

Study information

• Verified date: April 2023
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1491
• Est. completion date: May 27, 2021
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Death, Sudden, Cardiac
• Heart Arrest
• Infarction
• Myocardial Infarction
• Sudden Cardiac Arrest

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Bangladesh	National Heart Foundation Hospital and Research Institute	Dhaka
Brunei Darussalam	Gleneagles Jerudong Park Medical Centre	Brunei
China	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
Egypt	International Cardic Center	Alexandria
India	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
Indonesia	National Cardiovascular Center Harapan Kita	Jakarta
Indonesia	Rumah Sakit Cipto Mangunkusumo	Jakarta
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Sejong General Hospital	Gyeonggi-do
Korea, Republic of	Pusan National University Yangsan Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Keimyung University Dongsan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Malaysia	Hospital Serdang	Kajang
Malaysia	Queen Elizabeth II Hospital	Kota Kinabalu
Malaysia	Sarawak Heart Centre	Kota Samarahan
Pakistan	National Institute of Cardiovascular Diseases	Karachi
Philippines	Chinese General Hospital and Medical Center	Manila
Saudi Arabia	King Fahad Armed Forces Hospital	Jeddah
Saudi Arabia	Prince Sultan Cardiac Center	Riyadh
Singapore	Changi General Hospital	Singapore
South Africa	Mediclinic Panorama	Cape Town
South Africa	Netcare Unitas Hospital	Pretoria
Taiwan	Kaohsiung Chang Gung Memorial Hospital of CGMF	Kaohsiung
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
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Tunisia	The Military Hospital of Tunis	Montfleury

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

Bangladesh,  Brunei Darussalam,  China,  Egypt,  India,  Indonesia,  Korea, Republic of,  Malaysia,  Pakistan,  Philippines,  Saudi Arabia,  Singapore,  South Africa,  Taiwan,  Thailand,  Tunisia, 

References & Publications (4)

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. — View 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. 20 — View 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 — View 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, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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