Published Online: August 30, 2011. doi:10.1001/jama.2011.1280
Author Contributions: Dr Patel had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Patel, Smalling, Thiele, Barnhart, Cohen, French, Ohman.
Acquisition of data: Patel, Smalling, Thiele, Chew, Cohen, Perera.
Analysis and interpretation of data: Patel, Smalling, Thiele, Zhou, Barnhart, Chandra, Chew, Cohen, French, Perera, Ohman.
Drafting of the manuscript: Patel, Smalling, Zhou, Barnhart.
Critical revision of the manuscript for important intellectual content: Smalling, Thiele, Zhou, Barnhart, Chandra, Chew, Cohen, French, Perera, Ohman.
Statistical analysis: Zhou, Barnhart, Perera.
Obtained funding: Thiele, Ohman.
Administrative, technical, or material support: Thiele, French, Ohman.
Study supervision: Patel, Smalling, Thiele, Barnhart, Cohen,
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Patel reported that his institution has received grant funding and reimbursement for travel expenses from Maquet (formerly Datascope); that he has grants pending with the National Heart, Lung, and Blood Institute; that he is a board member for Genzyme; that he is a consultant for Bayer Healthcare and Ortho McNeil Jansen; and that he has received payment for lectures from theheart.org and the Duke Clinical Medicine Series. Dr Smalling reported that his institution has received grant funding and reimbursement for travel expenses from Maquet; and that he has received honoraria from Maquet. Dr Thiele reported that he has received honoraria and been reimbursed for travel expenses from Maquet. Dr Barnhart reported that her institution has received grant funding from Maquet. Dr Chew reported that his institution has received consulting fees from AstraZeneca Australia, Eli Lilly, and Abbott Vascular; and that he has received payment for lectures from AstraZeneca Australia. Dr Cohen reported that he has received fees for participating in review activities from Merck, Johnson & Johnson, and sanofi-aventis; that he is a board member for Johnson & Johnson, AstraZeneca, and sanofi-aventis; that he has provided expert testimony for Princeton Insurance; and that he has received payment for lectures from Merck, sanofi-aventis, and Bristol-Myers Squibb. Dr Perera reported that he has received payment for lectures and reimbursement for travel expenses from Maquet. Dr Ohman reported that his institution has received grant funding and reimbursement for travel expenses from Maquet; that he has grants pending with Daiichi Sankyo, Maquet, and Eli Lilly & Company; and that he is a consultant for AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Liposcience, Merck, Pozen Inc, Roche, sanofi-aventis, The Medicines Company, and WebMD. No other disclosures were reported.
Funding/Support: Funding for this trial was provided by Maquet (formerly Datascope).
Role of the Sponsor: The sponsor had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.
Independent Statistical Analysis: All statistical analyses were performed by Drs Barnhart and Zhou at the Duke Clinical Research Institute.
CRISP AMI Steering Committee Members: Manesh R. Patel, Holger Thiele, Richard W. Smalling, Praveen Chandra, Marc Cohen, Divaka Perera, Derek Chew, John French, E. Magnus Ohman.
Data and Safety Monitoring Board Members: Eric Bates, MD, University of Michigan, Ann Arbor; David Holmes, MD, Mayo Clinic, Rochester, Minnesota; Richard Trout, PhD, Rutgers University, New Brunswick, New Jersey.
CRISP AMI Trial Investigators:Australia: A. Sinhal, Flinders Medical Centre, Bedford Park (n = 4 patients enrolled). Belgium: P. Vranckx, Virga Jesse Hospital, Hasselt (n = 8). England: J. Blaxill, Leeds General Infirmary, Leeds (n = 32); M. Thomas, Saint Thomas Hospital, London (n = 18). Germany: H. Thiele, Universitatsklinikum Leipzig, Leipzig (n = 6); T. Schwab, University of Freiburg, Freiburg (n = 4); R. Strasser, Klinik III Fur Innere Medizin der Universitat zu Koln, Dresden (n = 1). India: S. Kumar, CARE Hospital, Hyderabad (n = 58); P. Singh, Baroda Heart Institute and Research Centre, Vadodara (n = 54); R. Passey, Sir Ganga Ram Hospital, New Delhi (n = 11); G. Reddy, Gurunanak CARE Hospital, Hyderabad (n = 5); P. Chandra, Medanta-The Medicity, Gurgaon (n = 4); N. Garg, Tagore Hospital and Heart Care Centre Pvt. Ltd, Jalandhar (n = 3); N. Khanna, Indraprastha Apollo Hospital, New Delhi (n = 2); S. Banerjee, Apollo Gleneagles Hospital, Kolkata (n = 2); K. Varghese, Saint John's Medical College and Hospital, Bangalore (n = 1). Ireland: H. Mc Cann, Mater Misercordiae Dublin, Dublin (n = 9). The Netherlands: N. Pijls, Catherina Hospital, Eindhoven (n = 28). Scotland: P. Henriksen, Royal Infirmary of Edinburgh, Edinburgh (n = 14). United States: J. Mills, Duke University Medical Center, Durham, North Carolina (n = 23); R. Smalling, University of Texas Health Science Center, Houston (n = 12); R. Bashir, Temple University Hospital, Philadelphia, Pennsylvania (n = 11); A. Weintraub, Tufts Medical Center, Boston, Massachusetts (n = 9); M. Cohen, Newark Beth Israel Medical Center, Newark, New Jersey (n = 8); F. Ling, University of Rochester Medical Center-Strong Memorial Hospital, Rochester, New York (n = 4); P. Casale, Lancaster General Hospital, Lancaster, Pennsylvania (n = 3); B. Brott, University of Alabama Medical Center, Birmingham (n = 2); L. Satler, Washington Hospital Center, Washington, DC (n = 1); R. Biederman, Allegheny General Hospital, Pittsburgh, Pennsylvania (n = 1); D. Shavelle, University of Southern California University Hospital, Los Angeles (n = 1).
Additional Contributions: We acknowledge Pamela L. Monds, AAS, and Karen W. Ramsey, BSN, MBA, MHA (both with Duke Clinical Research Institute, Durham, North Carolina) for operational excellence in helping conduct the study. We also acknowledge Elizabeth E. S. Cook, BA (Duke Clinical Research Institute) for her editorial support with the preparation of the manuscript. They did not receive compensation for their contributions.