Intracoronary Autologous Stem Cell Transplantation in ST Elevation Myocardial Infarction: TRACIA STUDY. - Full Text View

Purpose

The purpose of this study is to evaluate the ejection fraction (EF) increase at 6 months follow up and major adverse cardiovascular events (MACE) after intracoronary autologous stem cell transplantation in ST elevation myocardial infarction patients versus a control group.

Condition	Intervention	Phase
Acute Myocardial Infarction	Genetic: Stem Cell Transplantation	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Intracoronary Autologous Stem Cell Transplantation in ST Elevation Myocardial Infarction: TRACIA Study.

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by National Heart Institute, Mexico:

Primary Outcome Measures:

Evaluate the mean LVEF increase by magnetic resonance imaging (MRI) at 6 months of follow up between the stem cell group and the control group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the left ventricular end diastolic volume (LVEDV) and left ventricular end systolic volume (LVESV)with image magnetic resonance(IMR) at 6 months follow up between stem cell and control group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Evaluate the oxygen consumption during treadmill stress test (MVO2) by expired gases analysis and the incidence of MACE at 6 months follow up between stem cell and control group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Stem Cell Transplantation Group: Between the fifth and seventh day post-primary angioplasty (PTCA) we extract the stem cell from iliac crest and during the same day the patient undergoes to a new cardiac catheterization in which we perform the intracoronary injection (about 1-2 million of CD34 cells) through the infarct related artery by a PTCA "over-the-wire" catheter.	Genetic: Stem Cell Transplantation 1-2 million of CD34 cells injected through the infarct related artery by PTCA "over-the-wire" catheter during multiple sequences of balloon artery occlusion with a mean duration of 30 minutes. Other Name: Stem Cell

Detailed Description:

Experimental trials with bone marrow cell have suggested that adult stem cell can contribute to regeneration of infarcted myocardial muscle and increase the neovascularization of the ischemic tissue.

Post-myocardial infarction heart failure secondary to ventricular remodelation it's an increasing problem. A novel therapeutic approach for decrease this consequence is to induce the angiogeneses and regeneration of myocardial cells.

Many trials have shown benefits through the intracoronary injection of stem cell, however the clinical benefit is still controversial. The present trial is a randomized single blinded controlled trial designed to evaluate the improvement on EF and survival in post ST elevation myocardial infarction patients undergoing to intracoronary autologous stem cell transplantation.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Both gender patients between 20 and 75 years old with an acute myocardial infarction (less 24 hrs of symptoms) undergoing to primary angioplasty.
LVEF < o = 45% by MRI, radioisotopic ventriculography or echocardiogram.
Informed written consent.

Exclusion Criteria:

Cardiogenic Shock.
Post-myocardial infarction mechanical complication
Malignant ventricular arrythmias
History of malignant disease during the last five years.
Pregnancy
Renal chronic disease with a creatinine level > 2.6 mg/dl.
Any kind of stroke during the last year.
Any chronic disease that can affect the patient survival during the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725738

Contacts

Contact: Marco A Peña-Duque, MD	55732911 ext 1235-1236	penmar@cardiologia.org.mx
Contact: Luis J Uribe-González, MD, MSc	55732911 ext 1235-1236	ljhonathanug@hotmail.com

Locations

Mexico
National Institute of Cardiology "Ignacio Chávez" Mexico	Recruiting
Mexico, Distrito Federal, Mexico, 14080
Contact: Marco A Peña-Duque, MD 55732911 ext 1235-136 pernmar@cardiologia.org.mx
Contact: Luis J Uribe-González, MD, MSc 55732911 ext 1235-1236 ljhonathanug@hotmail.com
Sub-Investigator: Fause Attie, MD
Sub-Investigator: Rafael A Marin-López, MD
Sub-Investigator: Marco A Martínez-Ríos, MD
Sub-Investigator: Eva Calderón-Garcidueñas, MSc, PhD
Sub-Investigator: Luis J Uribe-González, Md, MSc
Sub-Investigator: Ana M Mejia, MD
Sub-Investigator: Felipe Masso, MD, MSc
Sub-Investigator: Carlos Martínez-Sánchez, MD
Sub-Investigator: Héctor González-Pacheco, MD
Sub-Investigator: David Bialostozky, MD
Sub-Investigator: Erick Alexanderson, MD
Sub-Investigator: Aloha Meave, MD
Sub-Investigator: Ilarraza Hermes, MD, MSc
Sub-Investigator: Ramón Villavicencio, MD
Sub-Investigator: Enrique Gómez, MD, MSc
Sub-Investigator: Jorge Gaspar, MD
Sub-Investigator: Eulo Lupi, MD
Sub-Investigator: Sergio Férez-Santander, MD
Sub-Investigator: Javier Figueroa, MD, MSc

Sponsors and Collaborators

National Heart Institute, Mexico

National Center of Blood Transfusion Mexico.

Investigators

Principal Investigator:	Marco A Peña-Duque, MD	National Institute of Cardiology "Ignacio Chávez" Mexico
Study Director:	Marco A Peña-Duque, MD	National Institute of Cardiology "Ignacio Chávez" Mexico
Study Chair:	Marco A Peña-Duque, MD	National Institute of Cardiology "Ignacio Chávez" Mexico

More Information

Publications:

Lange RA, Hillis LD. Reperfusion therapy in acute myocardial infarction. N Engl J Med. 2002 Mar 28;346(13):954-5. No abstract available.

Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. Review.

Giugliano RP, Braunwald E; The TIMI Study Group. Selecting the best reperfusion strategy in ST-elevation myocardial infarction: it's all a matter of time. Circulation. 2003 Dec 9;108(23):2828-30. No abstract available.

Pitt B, Remme W, Zannad F, Neaton J, Martinez F, Roniker B, Bittman R, Hurley S, Kleiman J, Gatlin M; Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study Investigators. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med. 2003 Apr 3;348(14):1309-21. Epub 2003 Mar 31. Erratum in: N Engl J Med. 2003 May 29;348(22):2271.

Pfeffer MA, McMurray JJ, Velazquez EJ, Rouleau JL, Køber L, Maggioni AP, Solomon SD, Swedberg K, Van de Werf F, White H, Leimberger JD, Henis M, Edwards S, Zelenkofske S, Sellers MA, Califf RM; Valsartan in Acute Myocardial Infarction Trial Investigators. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med. 2003 Nov 13;349(20):1893-906. Epub 2003 Nov 10. Erratum in: N Engl J Med. 2004 Jan 8;350(2):203.

Orlic D, Kajstura J, Chimenti S, Jakoniuk I, Anderson SM, Li B, Pickel J, McKay R, Nadal-Ginard B, Bodine DM, Leri A, Anversa P. Bone marrow cells regenerate infarcted myocardium. Nature. 2001 Apr 5;410(6829):701-5.

Kocher AA, Schuster MD, Szabolcs MJ, Takuma S, Burkhoff D, Wang J, Homma S, Edwards NM, Itescu S. Neovascularization of ischemic myocardium by human bone-marrow-derived angioblasts prevents cardiomyocyte apoptosis, reduces remodeling and improves cardiac function. Nat Med. 2001 Apr;7(4):430-6.

Strauer BE, Brehm M, Zeus T, Köstering M, Hernandez A, Sorg RV, Kögler G, Wernet P. Repair of infarcted myocardium by autologous intracoronary mononuclear bone marrow cell transplantation in humans. Circulation. 2002 Oct 8;106(15):1913-8.

Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H. Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial. Lancet. 2004 Jul 10-16;364(9429):141-8.

Fernández-Avilés F, San Román JA, García-Frade J, Fernández ME, Peñarrubia MJ, de la Fuente L, Gómez-Bueno M, Cantalapiedra A, Fernández J, Gutierrez O, Sánchez PL, Hernández C, Sanz R, García-Sancho J, Sánchez A. Experimental and clinical regenerative capability of human bone marrow cells after myocardial infarction. Circ Res. 2004 Oct 1;95(7):742-8. Epub 2004 Sep 9.

Schachinger V, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, Holschermann H, Yu J, Corti R, Mathey DG, Hamm CW, Suselbeck T, Assmus B, Tonn T, Dimmeler S, Zeiher AM; REPAIR-AMI Investigators. Intracoronary bone marrow-derived progenitor cells in acute myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1210-21.

Lunde K, Solheim S, Aakhus S, Arnesen H, Abdelnoor M, Egeland T, Endresen K, Ilebekk A, Mangschau A, Fjeld JG, Smith HJ, Taraldsrud E, Grogaard HK, Bjornerheim R, Brekke M, Muller C, Hopp E, Ragnarsson A, Brinchmann JE, Forfang K. Intracoronary injection of mononuclear bone marrow cells in acute myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1199-209.

Abdel-Latif A, Bolli R, Tleyjeh IM, Montori VM, Perin EC, Hornung CA, Zuba-Surma EK, Al-Mallah M, Dawn B. Adult bone marrow-derived cells for cardiac repair: a systematic review and meta-analysis. Arch Intern Med. 2007 May 28;167(10):989-97. Review.

Assmus B, Honold J, Schachinger V, Britten MB, Fischer-Rasokat U, Lehmann R, Teupe C, Pistorius K, Martin H, Abolmaali ND, Tonn T, Dimmeler S, Zeiher AM. Transcoronary transplantation of progenitor cells after myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1222-32.

Myers J, Prakash M, Froelicher V, Do D, Partington S, Atwood JE. Exercise capacity and mortality among men referred for exercise testing. N Engl J Med. 2002 Mar 14;346(11):793-801.

Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, Mark DB, McCallister BD, Mooss AN, O'Reilly MG, Winters WL, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Russell RO, Smith SC; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Committee to Update the 1997 Exercise Testing Guidelines. ACC/AHA 2002 guideline update for exercise testing: summary article. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). J Am Coll Cardiol. 2002 Oct 16;40(8):1531-40. No abstract available. Erratum in: J Am Coll Cardiol. 2006 Oct 17;48(8):1731.

Sutton MG, Sharpe N. Left ventricular remodeling after myocardial infarction: pathophysiology and therapy. Circulation. 2000 Jun 27;101(25):2981-8. Review. No abstract available.

Froelicher V, Myers J. Exercise and the heart. Fourth edition. Ed. Saunders. Philadelphia 2000. pp 456.

Responsible Party:	Marco Antonio Peña Duque MD Interventional Cardiologist, National Institute of Cardiology "Ignacio Chávez"
ClinicalTrials.gov Identifier:	NCT00725738 History of Changes
Other Study ID Numbers:	08-583
Study First Received:	July 28, 2008
Last Updated:	July 29, 2008
Health Authority:	Mexico: Ethics Committee

Keywords provided by National Heart Institute, Mexico:

Myocardial
Infarction,
Stem
Cell
Therapy

Additional relevant MeSH terms:

Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis

Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013