NCT01625949

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

June 25, 2012

Status Verified

June 1, 2012

Enrollment Period

3.3 years

First QC Date

June 20, 2012

Last Update Submit

June 22, 2012

Conditions

Acute Myocardial Infarction

Keywords

myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • left ventricular function

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

    3 Months

Secondary Outcomes (1)

  • change in functional capacity

    3 months

Study Arms (2)

Control Arm (Standard Therapy)

ACTIVE COMPARATOR

Control Arm Receiving The Standard Therapy including successful coronary intervention and stenting

Procedure: coronary dilatation and stenting

Intracoronary stem cells

EXPERIMENTAL

Intracoronary stem cells will be injected in the infarct related artery after a successful coronary dilatation and stenting

Procedure: Intracoronary stem cells injection

Interventions

Intracoronary stem cells injectionPROCEDURE

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.

Intracoronary stem cells
coronary dilatation and stentingPROCEDURE

coronary dilatation and stenting

Control Arm (Standard Therapy)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Left main disease or Triple vessel disease\[TVD\] needing surgery
  • Hypotension
  • Consent not given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, New Delhi, 110029, India

RECRUITING

Related Publications (4)

  • Strauer BE, Brehm M, Zeus T, Bartsch T, Schannwell C, Antke C, Sorg RV, Kogler G, Wernet P, Muller HW, Kostering M. Regeneration of human infarcted heart muscle by intracoronary autologous bone marrow cell transplantation in chronic coronary artery disease: the IACT Study. J Am Coll Cardiol. 2005 Nov 1;46(9):1651-8. doi: 10.1016/j.jacc.2005.01.069.

    PMID: 16256864BACKGROUND

  • 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.

    PMID: 18285565BACKGROUND

  • 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.

    PMID: 16172284BACKGROUND

  • 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.

    PMID: 17379833BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Stents

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Sandeep Seth, DM

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Balram Airan, DM

    All India Institute of Medical Sciences

    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

    STUDY CHAIR

Central Study Contacts

Sandeep Seth, DM

CONTACT

91-11-26594970aiimscardiology@yahoo.co.in

S Seth

CONTACT

drsandeepseth@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Additional Professor, Department of Cardiology

Study Record Dates

First Submitted

June 20, 2012

First Posted

June 22, 2012

Study Start

March 1, 2011

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

June 25, 2012

Record last verified: 2012-06

Locations

IN(1)