- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01625949
Stem Cell Therapy in Patients With Myocardial Infarction and Persistent Total Occlusion of Infarct Related Artery (COAT)
Study of Stem Cell Therapy in Patients With Myocardial Infarction and Persistent Total Occlusion of Infarct Related Artery
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sandeep Seth, DM
- Phone Number: 91-11-26594970
- Email: aiimscardiology@yahoo.co.in
Study Contact Backup
- Name: S Seth
- Email: drsandeepseth@hotmail.com
Study Locations
-
-
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New Delhi, India, 110029
- Recruiting
- All India Institute of Medical Sciences
-
Contact:
- S Seth
- Email: drsandeepseth@hotmail.com
-
Contact:
- Sandeep Seth, DM
- Phone Number: 4970 91-11-26594970
- Email: aiimscardiology@yahoo.co.in
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Arm (Standard Therapy)
Control Arm Receiving The Standard Therapy including successful coronary intervention and stenting
|
coronary dilatation and stenting
|
Experimental: Intracoronary stem cells
Intracoronary stem cells will be injected in the infarct related artery after a successful coronary dilatation and stenting
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
left ventricular function
Time Frame: 3 Months
|
Change in left ventricular function (assessed by Nuclear imaging and ECHO) and change in myocardial viability [assessed by PET].
|
3 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in functional capacity
Time Frame: 3 months
|
change in functional capacity as assessed by 6 minute walk test, quality of life assessment, first occurrence of recurrent MI,
|
3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: V K Bahl, DM, AIIMS, New Delhi
- Study Chair: Balram Bhargava, DM, AIIMS, New Delhi
- Study Chair: Chetan Patel, AIIMS, New Delhi
- Study Chair: Sujata Mohanty, AIIMS, New Delhi
- Study Chair: Rajiv Narang, DM, AIIMS, New Delhi
- Study Chair: S Ramakrishnan, DM, AIIMS, New Delhi
- Study Chair: K C Goswami, DM, AIIMS, New Delhi
- Study Chair: Rakesh Yadav, DM, AIIMS, New Delhi
- Study Chair: Ambuj Roy, DM, AIIMS, New Delhi
- Study Chair: G Karthikeyan, DM, AIIMS, New Delhi
- Study Chair: Gautam Sharma, DM, AIIMS, New Delhi
- Study Chair: Sandeep Singh, DM, AIIMS, New Delhi
- Study Chair: Sandeep Mishra, DM, AIIMS, New Delhi
- Study Chair: Nitish Naik, DM, AIIMS, New Delhi
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICMR project 80/3/2010-BMS
- I-676 (Other Grant/Funding Number: Indian council of medical research)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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