Clinical trial NCT01625949: Stem Cell Therapy in Patients With Myocardial Infarction and Persistent Total Occlusion of Infarct Related Artery
Official title: Study of Stem Cell Therapy in Patients With Myocardial Infarction and Persistent Total Occlusion of Infarct Related Artery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: myocardial infarction
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Indian Council of Medical Research
First posted: 2012-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: left ventricular function
timeFrame: 3 Months
Secondary outcomes:
measure: change in functional capacity
timeFrame: 3 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
Study officials:
affiliation: All India Institute of Medical Sciences
name: Sandeep Seth, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: All India Institute of Medical Sciences
name: Balram Airan, DM
role: STUDY_CHAIR
affiliation: AIIMS, New Delhi
name: V K Bahl, DM
role: STUDY_CHAIR
affiliation: AIIMS, New Delhi
name: Balram Bhargava, DM
role: STUDY_CHAIR
affiliation: AIIMS, New Delhi
name: Chetan Patel
role: STUDY_CHAIR
affiliation: AIIMS, New Delhi
name: Sujata Mohanty
role: STUDY_CHAIR
affiliation: AIIMS, New Delhi
name: Rajiv Narang, DM
role: STUDY_CHAIR
affiliation: AIIMS, New Delhi
name: S Ramakrishnan, DM
role: STUDY_CHAIR
affiliation: AIIMS, New Delhi
name: K C Goswami, DM
role: STUDY_CHAIR
affiliation: AIIMS, New Delhi
name: Rakesh Yadav, DM
role: STUDY_CHAIR
affiliation: AIIMS, New Delhi
name: Ambuj Roy, DM
role: STUDY_CHAIR
affiliation: AIIMS, New Delhi
name: G Karthikeyan, DM
role: STUDY_CHAIR
affiliation: AIIMS, New Delhi
name: Gautam Sharma, DM
role: STUDY_CHAIR
affiliation: AIIMS, New Delhi
name: Sandeep Singh, DM
role: STUDY_CHAIR
affiliation: AIIMS, New Delhi
name: Sandeep Mishra, DM
role: STUDY_CHAIR
affiliation: AIIMS, New Delhi
name: Nitish Naik, DM
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.