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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
Dr Sandeep Seth, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01625949
First received: June 20, 2012
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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 Intervention
Acute Myocardial Infarction
Procedure: Intracoronary stem cells injection
Procedure: coronary dilatation and stenting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • left ventricular function [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    change in functional capacity as assessed by 6 minute walk test, quality of life assessment, first occurrence of recurrent MI,


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625949

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

Locations
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
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

Publications:
Responsible Party: Dr Sandeep Seth, Additional Professor, Department of Cardiology, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01625949     History of Changes
Other Study ID Numbers: ICMR project 80/3/2010-BMS, I-676
Study First Received: June 20, 2012
Last Updated: June 22, 2012
Health Authority: India: Indian Council of Medical Research

Keywords provided by All India Institute of Medical Sciences, New Delhi:
myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014