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

June 22, 2012 updated by: Dr Sandeep Seth, All India Institute of Medical Sciences, New Delhi

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

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

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

June 21, 2012

First Posted (Estimate)

June 22, 2012

Study Record Updates

Last Update Posted (Estimate)

June 25, 2012

Last Update Submitted That Met QC Criteria

June 22, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

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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