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

Not Applicable

• Conditions: Acute Myocardial Infarction
• Interventions: Procedure: coronary dilatation and stenting; Procedure: Intracoronary stem cells injection

• Registration Number: NCT01625949
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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.

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 Timeline

• Study Start: 2011-03
• Status Verified: 2012-06
• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-22
• Last Update Submitted: 2012-06-22
• Last Update Posted: 2012-06-25
• Primary Completion: 2014-06
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm (Standard Therapy)	coronary dilatation and stenting	Control Arm Receiving The Standard Therapy including successful coronary intervention and stenting
Intracoronary stem cells	Intracoronary stem cells injection	Intracoronary stem cells will be injected in the infarct related artery after a successful coronary dilatation and stenting

Primary Outcome Measures

Name	Time	Method
left ventricular function	3 Months	Change in left ventricular function (assessed by Nuclear imaging and ECHO) and change in myocardial viability \[assessed by PET\].

Secondary Outcome Measures

Name	Time	Method
change in functional capacity	3 months	change in functional capacity as assessed by 6 minute walk test, quality of life assessment, first occurrence of recurrent MI,

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 New Delhi, India