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Stem Cell Therapy in Patients With Myocardial Infarction and Persistent Total Occlusion of Infarct Related Artery (COAT)

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ClinicalTrials.gov Identifier: NCT01625949
Recruitment Status : Unknown
Verified June 2012 by Dr Sandeep Seth, All India Institute of Medical Sciences, New Delhi.
Recruitment status was:  Recruiting
First Posted : June 22, 2012
Last Update Posted : June 25, 2012
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
Dr Sandeep Seth, All India Institute of Medical Sciences, New Delhi

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Procedure: Intracoronary stem cells injection Procedure: coronary dilatation and stenting Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Stem Cell Therapy in Patients With Myocardial Infarction and Persistent Total Occlusion of Infarct Related Artery
Study Start Date : March 2011
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control Arm (Standard Therapy)
Control Arm Receiving The Standard Therapy including successful coronary intervention and stenting
 Procedure: coronary dilatation 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
 Procedure: Intracoronary stem cells injection
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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].


Secondary Outcome Measures :
  1. 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,


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age:18 to 80 years
  2. Sex:Both
  3. Recent MI (3-28 d)
  4. Obstructed artery needing intervention
  5. consent for stem cell therapy

Exclusion Criteria:

  1. Left main disease or Triple vessel disease[TVD] needing surgery
  2. Hypotension
  3. Consent not given
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625949


Contacts
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Contact: Sandeep Seth, DM 91-11-26594970 aiimscardiology@yahoo.co.in
Contact: S Seth drsandeepseth@hotmail.com

Locations
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India
All India Institute of Medical Sciences Recruiting
New Delhi, India, 110029
Contact: Sandeep Seth, DM    91-11-26594970 ext 4970    aiimscardiology@yahoo.co.in   
Contact: S Seth       drsandeepseth@hotmail.com   
Principal Investigator: Sandeep Seth, DM         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Indian Council of Medical Research
Investigators
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Principal Investigator: Sandeep Seth, DM All India Institute of Medical Sciences, New Delhi
Study Chair: Balram Airan, DM All India Institute of Medical Sciences, New Delhi
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
More Information
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Publications:

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Responsible Party: Dr Sandeep Seth, Additional Professor, Department of Cardiology, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01625949    
Other Study ID Numbers: ICMR project 80/3/2010-BMS
I-676 ( Other Grant/Funding Number: Indian council of medical research )
First Posted: June 22, 2012    Key Record Dates
Last Update Posted: June 25, 2012
Last Verified: June 2012
Keywords provided by Dr Sandeep Seth, All India Institute of Medical Sciences, New Delhi:
myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases