| CTRI Number |
CTRI/2019/01/017004 [Registered on: 09/01/2019] Trial Registered Prospectively |
| Last Modified On: |
30/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Post Market |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To characterize the care pathway flow of postâ€acute myocardial infarction (MI) patients as a result of standard assessments of left ventricular ejection fraction
|
|
Scientific Title of Study
|
Improve SCA Bridge |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 1.0; 27 JUL 2018 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajit Mullasari |
| Designation |
Director Cardiology |
| Affiliation |
The Madras Medical Mission |
| Address |
The Madras Medical Mission Hospital
4A, Dr, J J Nagar, Mogappair, Chennai, Tamil Nadu 600037
Chennai
TAMIL NADU
600037
India |
| Phone |
9841271361 |
| Fax |
|
| Email |
icvddoctors@mmm.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinay Rajan PhD |
| Designation |
Clinical Research Manager |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt. Ltd.
Solitaire Corporate Park, Bldg No. 12, 4th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02233074700 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinay Rajan PhD |
| Designation |
Clinical Research Manager |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt. Ltd.
Solitaire Corporate Park, Bldg No. 12, 4th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02233074700 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
|
Source of Monetary or Material Support
|
| India Medtronic Pvt Ltd Solitaire Corporate Park, Bldg No. 12, 4th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093
|
|
|
Primary Sponsor
|
| Name |
India Medtronic Pvt Ltd |
| Address |
Solitaire Corporate Park, Bldg No. 12, 4th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093
|
| Type of Sponsor |
Other [Medical Device Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Pakistan
Indonesia
Malaysia
Other
Philippines
Saudi Arabia
Singapore
Bangladesh
Brunei Darussalam
China
Egypt
South Africa
Taiwan
Thailand
Tunisia |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nitish Naik |
All India Institute of Medical Sciences |
Room no 102, 1st Floor, Old OT block, Ansari Nagar, Delhi-110029
New Delhi
DELHI |
011-26593218
nitishnaik@yahoo.co.in |
| Dr Upendra Kaul |
Batra Hospital and Medical Research Institute |
1 Tuglakabad Institutional Area M B Road new Delhi
New Delhi
DELHI |
9811150518
kaul.upendra@gmail.com |
| Dr Gurpreet Singh Wander |
Dayanand Medical College and Hospital |
Research and development centre
Hero DMC Heart Institute
Dayanand Medical College and Hospital, Civil Lines,
Tagore Road, Ludhiana, Punjab-141001
Ludhiana
PUNJAB |
9815545316
drgswander@yahoo.com |
| DrJitendra Singh Makkar |
Eternal Hospital |
3 A, Jagatpura Road, Near Jawahar Circle, Jaipur - 302020
Jaipur
RAJASTHAN |
0141-5174000
drjitendra.makkar@eternalheart.org |
| Dr Ashok Sheth |
Fortis Escorts Heart Institute |
Room No : A - 23, 2nd Floor
RC Building, Residential Tower
Okhla Road
New Delhi
DELHI |
9810025814
ashok.seth@fortishealthcare.com |
| Dr Narasimha Pai |
Kasturba medical college Hospital (KMC Hospital) |
Dr B.R. Ambedkar Circle
(Jothi), Mangalore
Dakshina Kannada
KARNATAKA |
9449664407
narasimhapai@yahoo.com |
| Dr Fazila Tunn Nesa Malik |
National Heart Foundation Hospital and Research Institute |
Mirpur 2 Dhaka-1216
|
880-2-8113515
fazilamalik@yahoo.com |
| Dr Rajesh Vijayvergiya |
Post Graduate Institute of Medical Sciences |
Chandigarh 160012
Chandigarh
CHANDIGARH |
9815221856
rajeshvijay999@hotmail.com |
| Dr Ajit Mullasari |
The Madras Medical Misison |
4A, Dr, J J Nagar, Mogappair, Chennai, Tamil Nadu 600037
Chennai
TAMIL NADU |
9841271361
icvddoctors@mmm.org.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Eternal Heart Care Centre & Research Institute, Institutional Ethics committee |
Approved |
| Ethic Committee, All India Institute of Medical Sciences |
Submittted/Under Review |
| Ethics Committee, National Heart Foundation |
Approved |
| Institutional Ethics Commitee , Dayanand Medical College and Hospital |
Approved |
| Institutional Ethics Commitee , Forits Escorts |
Approved |
| Institutional Ethics Committee , PGIMER |
Approved |
| Institutional Ethics committee, MMM Hospital, |
Approved |
| MAHE Ethics committee |
Approved |
| Scientific Research & Ethical review committee, Batra Hospital and Medical Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 and above ( or meet age requirements per local law)
Patients who have acute Myocardial Infarction ( MI) ( STEMI of Non-STEMI) less than equal to 30 days of study enrollment and have a LVEF less than 50% measurement less than equal to 14 days post-acute MI
Willing and able to give valid Informed Consent
|
|
| ExclusionCriteria |
| Details |
Patient has previously recieved 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 and 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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To characterize the proportion of post-acute MI patients who are referred for suddden cardiac death (SCD) risk startification and management. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Characterize the proportion of postâ€acute MI patients who are known to be indicated for an
ICD/CRTâ€D within 12 months postâ€acute MI.
Characterize the proportion of postâ€acute MI patients who receive an ICD/CRTâ€D within 12
months postâ€acute MI.
Summarize the referral and implant refusal rationale.
Characterize the proportion of postâ€acute MI patients who experience cardiovascular mortality
Determine how the ejection fraction evolves over 3 months following an acute MI. |
3 months and 1 year |
|
|
Target Sample Size
|
Total Sample Size="2400"
Sample Size from India="340"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/11/2018 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
The Medtronic study team will collaborate to publish the results of the study in an appropriate/highest impact local (Indian) and global publications. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Left ventricular dysfunction following an acute MI identifies patients at higher risk of sudden cardiac arrest (SCA) and sudden cardiac death SCD). SCD remains a leading cause of death in those who received revascularization, accounting for up to 40% of total deaths. The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of post-acute MI patients as a result of standard assessments of left ventricular ejection fraction in acute phase less than equal to 14 days post- acute MI) and chronic phase greater than or equal to 40-90 days post-acute MI). Specifically, how many patients are referred for sudden cardiac death (SCD) risk stratification and management, indicated for ICD/CRT-D implant, and how many receive such devices within 12 months of experiencing an MI
|