American Heart Journal
Volume 156, Issue 5 , Pages 954-963 , November 2008

Safety and efficacy of consecutive cycles of granulocyte-colony stimulating factor, and an intracoronary CD133+ cell infusion in patients with chronic refractory ischemic heart disease: The G-CSF in Angina patients with IHD to stimulate Neovascularization (GAIN I) trial

  • Jason C. Kovacic, FRACP, PhD

      Affiliations

    • Victor Chang Cardiac Research Institute, University of New South Wales, Sydney, New South Wales, Australia
    • St Vincent's Hospital, University of New South Wales, Sydney, New South Wales, Australia
    • Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
    • Current appointment: Translational Medicine Branch, National Heart, Lung and Blood Institute, Bethesda, MD
    • ,
  • Peter Macdonald, FRACP, MD, PhD

      Affiliations

    • Victor Chang Cardiac Research Institute, University of New South Wales, Sydney, New South Wales, Australia
    • St Vincent's Hospital, University of New South Wales, Sydney, New South Wales, Australia
    • Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
    • ,
  • Michael P. Feneley, FRACP, MD

      Affiliations

    • Victor Chang Cardiac Research Institute, University of New South Wales, Sydney, New South Wales, Australia
    • St Vincent's Hospital, University of New South Wales, Sydney, New South Wales, Australia
    • Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
    • ,
  • David W.M. Muller, FRACP, MD

      Affiliations

    • Victor Chang Cardiac Research Institute, University of New South Wales, Sydney, New South Wales, Australia
    • St Vincent's Hospital, University of New South Wales, Sydney, New South Wales, Australia
    • Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
    • ,
  • Judith Freund, FRACP

      Affiliations

    • St Vincent's Hospital, University of New South Wales, Sydney, New South Wales, Australia
    • Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
    • ,
  • Anthony Dodds, FRACP

      Affiliations

    • St Vincent's Hospital, University of New South Wales, Sydney, New South Wales, Australia
    • Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
    • ,
  • Sam Milliken, FRACP

      Affiliations

    • St Vincent's Hospital, University of New South Wales, Sydney, New South Wales, Australia
    • Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
    • ,
  • Helen Tao, MD, PhD

      Affiliations

    • St Vincent's Hospital, University of New South Wales, Sydney, New South Wales, Australia
    • Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
    • ,
  • Silviu Itescu, FRACP

      Affiliations

    • Columbia University, New York, New York
    • ,
  • John Moore, FRACP, MD

      Affiliations

    • St Vincent's Hospital, University of New South Wales, Sydney, New South Wales, Australia
    • Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
    • ,
  • David Ma, FRACP, MD

      Affiliations

    • St Vincent's Hospital, University of New South Wales, Sydney, New South Wales, Australia
    • Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
    • ,
  • Robert M. Graham, FRACP, MD

      Affiliations

    • Victor Chang Cardiac Research Institute, University of New South Wales, Sydney, New South Wales, Australia
    • St Vincent's Hospital, University of New South Wales, Sydney, New South Wales, Australia
    • Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
    • Corresponding Author InformationReprint requests: Robert Graham, FRACP, MD, Victor Chang Cardiac Research Institute, 384 Victoria Street, Darlinghurst, NSW, 2010, Australia.

Received 18 September 2007 ,Accepted 14 April 2008.

References 

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  2. Suzuki K, Nagashima K, Arai M, et al. Effect of granulocyte colony-stimulating factor treatment at a low dose but for a long duration in patients with coronary heart disease. Circ J. 2006;70:430–437
  3. Wang Y, Tagil K, Ripa RS, et al. Effect of mobilization of bone marrow stem cells by granulocyte colony stimulating factor on clinical symptoms, left ventricular perfusion and function in patients with severe chronic ischemic heart disease. Int J Cardiol. 2005;100:477–483
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  11. Mark DB, Shaw L, Harrell FE, et al. Prognostic value of a treadmill exercise score in outpatients with suspected coronary artery disease. N Engl J Med. 1991;325:849–853
  12. Kovacic JC, Macdonald P, Freund J, et al. Profound thrombocytopenia related to G-CSF. Am J Hematol. 2007;82:229–230
  13. Allen KB, Dowling RD, Fudge TL, et al. Comparison of transmyocardial revascularization with medical therapy in patients with refractory angina. N Engl J Med. 1999;341:1029–1036
  14. Leon MB, Kornowski R, Downey WE, et al. A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease. J Am Coll Cardiol. 2005;46:1812–1819
  15. Losordo DW, Schatz RA, White CJ, et al. Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial. Circulation. 2007;115:3165–3172
  16. Wallace TW, Abdullah SM, Drazner MH, et al. Prevalence and determinants of troponin T elevation in the general population. Circulation. 2006;113:1958–1965
  17. Perna ER, Macin SM, Canella JP, et al. Ongoing myocardial injury in stable severe heart failure: value of cardiac troponin T monitoring for high-risk patient identification. Circulation. 2004;110:2376–2382
  18. Vikenes K, Westby J, Matre K, et al. Release of cardiac troponin I after temporally graded acute coronary ischaemia with electrocardiographic ST depression. Int J Cardiol. 2002;85:243–251

 The study was approved by the St Vincent's Hospital human research ethics committee, registered with the Australian Clinical Trials Registry (no. 12605000050651), supervised by an independent data and safety monitoring board (DSMB), and conducted with the informed consent of all subjects. Enrollment commenced January 2004, with the final follow-up scan performed July 2006.

PII: S0002-8703(08)00657-1

doi: 10.1016/j.ahj.2008.04.034

American Heart Journal
Volume 156, Issue 5 , Pages 954-963 , November 2008

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