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| ID | Type | Description | Link |
|---|---|---|---|
| I-676 | Other Grant/Funding Number | Indian council of medical research |
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| Name | Class |
|---|---|
| Indian Council of Medical Research | OTHER_GOV |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm (Standard Therapy) | Active Comparator | Control Arm Receiving The Standard Therapy including successful coronary intervention and stenting |
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| Intracoronary stem cells | Experimental | Intracoronary stem cells will be injected in the infarct related artery after a successful coronary dilatation and stenting |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracoronary stem cells injection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| left ventricular function | Change in left ventricular function (assessed by Nuclear imaging and ECHO) and change in myocardial viability [assessed by PET]. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| change in functional capacity | change in functional capacity as assessed by 6 minute walk test, quality of life assessment, first occurrence of recurrent MI, | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandeep Seth, DM | Contact | 91-11-26594970 | aiimscardiology@yahoo.co.in | |
| S Seth | Contact | drsandeepseth@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sandeep Seth, DM | All India Institute of Medical Sciences | Principal Investigator |
| Balram Airan, DM | All India Institute of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences | Recruiting | New Delhi | New Delhi | 110029 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16256864 | Background | 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. | |
| 18285565 |
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|
| coronary dilatation and stenting | Procedure | coronary dilatation and stenting |
|
| V K Bahl, DM |
| All India Institute of Medical Sciences |
| Study Chair |
| Balram Bhargava, DM | All India Institute of Medical Sciences | Study Chair |
| Chetan Patel | All India Institute of Medical Sciences | Study Chair |
| Sujata Mohanty | All India Institute of Medical Sciences | Study Chair |
| Rajiv Narang, DM | All India Institute of Medical Sciences | Study Chair |
| S Ramakrishnan, DM | All India Institute of Medical Sciences | Study Chair |
| K C Goswami, DM | All India Institute of Medical Sciences | Study Chair |
| Rakesh Yadav, DM | All India Institute of Medical Sciences | Study Chair |
| Ambuj Roy, DM | All India Institute of Medical Sciences | Study Chair |
| G Karthikeyan, DM | All India Institute of Medical Sciences | Study Chair |
| Gautam Sharma, DM | All India Institute of Medical Sciences | Study Chair |
| Sandeep Singh, DM | All India Institute of Medical Sciences | Study Chair |
| Sandeep Mishra, DM | All India Institute of Medical Sciences | Study Chair |
| Nitish Naik, DM | All India Institute of Medical Sciences | Study Chair |
| 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. |
| 16172284 | Background | 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. |
| 17379833 | Background | 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. |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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