Stem Cell Therapy in Patients With Myocardial Infarction and Persistent Total Occlusion of Infarct Related Artery (COAT)
Primary Purpose
Acute Myocardial Infarction
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Intracoronary stem cells injection
coronary dilatation and stenting
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring myocardial infarction
Eligibility Criteria
Inclusion Criteria:
- Age:18 to 80 years
- Sex:Both
- Recent MI (3-28 d)
- Obstructed artery needing intervention
- consent for stem cell therapy
Exclusion Criteria:
- Left main disease or Triple vessel disease[TVD] needing surgery
- Hypotension
- Consent not given
Sites / Locations
- All India Institute of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Arm (Standard Therapy)
Intracoronary stem cells
Arm Description
Control Arm Receiving The Standard Therapy including successful coronary intervention and stenting
Intracoronary stem cells will be injected in the infarct related artery after a successful coronary dilatation and stenting
Outcomes
Primary Outcome Measures
left ventricular function
Change in left ventricular function (assessed by Nuclear imaging and ECHO) and change in myocardial viability [assessed by PET].
Secondary Outcome Measures
change in functional capacity
change in functional capacity as assessed by 6 minute walk test, quality of life assessment, first occurrence of recurrent MI,
Full Information
NCT ID
NCT01625949
First Posted
June 20, 2012
Last Updated
June 22, 2012
Sponsor
All India Institute of Medical Sciences, New Delhi
Collaborators
Indian Council of Medical Research
1. Study Identification
Unique Protocol Identification Number
NCT01625949
Brief Title
Stem Cell Therapy in Patients With Myocardial Infarction and Persistent Total Occlusion of Infarct Related Artery
Acronym
COAT
Official Title
Study of Stem Cell Therapy in Patients With Myocardial Infarction and Persistent Total Occlusion of Infarct Related Artery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
Collaborators
Indian Council of Medical Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background: When an acute myocardial infarction occurs, the artery supplying the infarct zone should be opened within twenty four hours of onset of infarction. This has clearly been shown to be beneficial.
If the patient presents later than 24 hours of onset, at that stage a large part of the damage to the heart is irreversible. Intervening at this stage (beyond 24 hours is controversial). Some trials suggest that opening the artery even at this stage positively modifies the remodeling process while other trials suggest that such a benefit is not seen.
Hypothesis: Opening an infarct related artery after 24 hours (until 6 months) and combining it with intracoronary stem cell therapy may provide incremental benefit.It is possible that the lack of benefit seen with late revascularization (>24 hrs) after MI may be offset by giving intracoronary stem cells after opening the artery.
Detailed Description
Objectives
The benefit of opening an infarct related artery after the period of myocardial salvage (In patients who do not come to medical attention within 24 hrs of an infarctions) has been questioned in recent trials. On the other hand, Stem cell therapy after myocardial infarction has been shown to improve myocardial function both in the acute and chronic phases. It is possible that the lack of benefit seen with late revascularization (>24 hrs) after MI may be offset by giving intracoronary stem cells after opening the artery. Patients with recent myocardial infarction (MI) and occluded infarct related arteries supplying a large myocardial territory and with reduced ejection fraction will be randomized to a percutaneous coronary intervention (PCI) arm and a PCI plus stem cell arm .
The objective of the trial is to demonstrate that opening an infarct related artery after 24 hours and before six months and following it with intracoronary stem cell therapy may provide incremental benefit.
The primary objective
To demonstrate benefits in left ventricular recovery (improvement in function by echocardiogram and Nuclear imaging: Multigated acquisition [MUGA], reduction in scar size by tetrofosmin scan/Positron Emission Tomography[PET]. )
The secondary objectives
To demonstrate improvement in functional capacity as assessed by 6 minute walk test and quality of life assessment, along with reduction of first occurrence of recurrent MI, hospitalization/treatment of New York Heart Association class IV congestive heart failure, or death
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
myocardial infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Arm (Standard Therapy)
Arm Type
Active Comparator
Arm Description
Control Arm Receiving The Standard Therapy including successful coronary intervention and stenting
Arm Title
Intracoronary stem cells
Arm Type
Experimental
Arm Description
Intracoronary stem cells will be injected in the infarct related artery after a successful coronary dilatation and stenting
Intervention Type
Procedure
Intervention Name(s)
Intracoronary stem cells injection
Intervention Description
Intracoronary stem cells will be injected in the infarct related artery after a successful coronary dilatation and stenting autologous bone marrow stem cells from iliac crest 60 ml bone marrow will be extracted and purified for mononuclear cells which will be injected.
Intervention Type
Procedure
Intervention Name(s)
coronary dilatation and stenting
Intervention Description
coronary dilatation and stenting
Primary Outcome Measure Information:
Title
left ventricular function
Description
Change in left ventricular function (assessed by Nuclear imaging and ECHO) and change in myocardial viability [assessed by PET].
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
change in functional capacity
Description
change in functional capacity as assessed by 6 minute walk test, quality of life assessment, first occurrence of recurrent MI,
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age:18 to 80 years
Sex:Both
Recent MI (3-28 d)
Obstructed artery needing intervention
consent for stem cell therapy
Exclusion Criteria:
Left main disease or Triple vessel disease[TVD] needing surgery
Hypotension
Consent not given
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandeep Seth, DM
Phone
91-11-26594970
Email
aiimscardiology@yahoo.co.in
First Name & Middle Initial & Last Name or Official Title & Degree
S Seth
Email
drsandeepseth@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandeep Seth, DM
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Balram Airan, DM
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
V K Bahl, DM
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Balram Bhargava, DM
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chetan Patel
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sujata Mohanty
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rajiv Narang, DM
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
S Ramakrishnan, DM
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
K C Goswami, DM
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rakesh Yadav, DM
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ambuj Roy, DM
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
G Karthikeyan, DM
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gautam Sharma, DM
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sandeep Singh, DM
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sandeep Mishra, DM
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nitish Naik, DM
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Study Chair
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandeep Seth, DM
Phone
91-11-26594970
Ext
4970
Email
aiimscardiology@yahoo.co.in
First Name & Middle Initial & Last Name & Degree
S Seth
Email
drsandeepseth@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sandeep Seth, DM
12. IPD Sharing Statement
Citations:
PubMed Identifier
16256864
Citation
Strauer BE, Brehm M, Zeus T, Bartsch T, Schannwell C, Antke C, Sorg RV, Kogler G, Wernet P, Muller HW, Kostering M. Regeneration of human infarcted heart muscle by intracoronary autologous bone marrow cell transplantation in chronic coronary artery disease: the IACT Study. J Am Coll Cardiol. 2005 Nov 1;46(9):1651-8. doi: 10.1016/j.jacc.2005.01.069.
Results Reference
background
PubMed Identifier
18285565
Citation
Menasche P, Alfieri O, Janssens S, McKenna W, Reichenspurner H, Trinquart L, Vilquin JT, Marolleau JP, Seymour B, Larghero J, Lake S, Chatellier G, Solomon S, Desnos M, Hagege AA. The Myoblast Autologous Grafting in Ischemic Cardiomyopathy (MAGIC) trial: first randomized placebo-controlled study of myoblast transplantation. Circulation. 2008 Mar 4;117(9):1189-200. doi: 10.1161/CIRCULATIONAHA.107.734103. Epub 2008 Feb 19.
Results Reference
background
PubMed Identifier
16172284
Citation
Dib N, Michler RE, Pagani FD, Wright S, Kereiakes DJ, Lengerich R, Binkley P, Buchele D, Anand I, Swingen C, Di Carli MF, Thomas JD, Jaber WA, Opie SR, Campbell A, McCarthy P, Yeager M, Dilsizian V, Griffith BP, Korn R, Kreuger SK, Ghazoul M, MacLellan WR, Fonarow G, Eisen HJ, Dinsmore J, Diethrich E. Safety and feasibility of autologous myoblast transplantation in patients with ischemic cardiomyopathy: four-year follow-up. Circulation. 2005 Sep 20;112(12):1748-55. doi: 10.1161/CIRCULATIONAHA.105.547810.
Results Reference
background
PubMed Identifier
17379833
Citation
Assmus B, Fischer-Rasokat U, Honold J, Seeger FH, Fichtlscherer S, Tonn T, Seifried E, Schachinger V, Dimmeler S, Zeiher AM; TOPCARE-CHD Registry. Transcoronary transplantation of functionally competent BMCs is associated with a decrease in natriuretic peptide serum levels and improved survival of patients with chronic postinfarction heart failure: results of the TOPCARE-CHD Registry. Circ Res. 2007 Apr 27;100(8):1234-41. doi: 10.1161/01.RES.0000264508.47717.6b. Epub 2007 Mar 22.
Results Reference
background
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Stem Cell Therapy in Patients With Myocardial Infarction and Persistent Total Occlusion of Infarct Related Artery
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