Published Online: November 6, 2012. doi:10.1001/jama.2012.28726
Author Contributions: Dr Moyé 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: Traverse, Henry, Willerson, Ellis, Forder, Hatzopoulos, Penn, Raveendran, Vaughan, Lai, Piller, Simpson, Loghin, Aguilar, Bettencourt, Skarlatos, Gordon, Kwak, Moyé, Simari.
Acquisition of data: Traverse, Henry, Pepine, Willerson, Zhao, Ellis, Forder, Anderson, Penn, Perin, Chambers, Raveendran, Lambert, Lerman, Simon, Gee, Taylor, Cogle, Olson, Bowman, Francescon, Geither, Handberg, Kappenman, Westbrook, Piller, Simpson, Zierold, Sayre, Vojvodic, Moyé.
Analysis and interpretation of data: Traverse, Henry, Willerson, Zhao, Ellis, Forder, Anderson, Penn, Chambers, Raveendran, Vaughan, Lai, Gee, Taylor, Thomas, Baraniuk, Richman, Zierold, Bettencourt, Gordon, Ebert, Kwak, Moyé, Simari.
Drafting of the manuscript: Traverse, Henry, Willerson, Hatzopoulos, Penn, Perin, Gee, Geither, Kappenman, Simpson, Moyé, Simari.
Critical revision of the manuscript for important intellectual content: Traverse, Henry, Pepine, Willerson, Zhao, Ellis, Forder, Anderson, Penn, Perin, Chambers, Baran, Raveendran, Lambert, Lerman, Simon, Vaughn, Lai, Taylor, Cogle, Thomas, Olson, Bowman, Francescon, Handberg, Westbrook, Piller, Baraniuk, Loghin, Aguilar, Richman, Zierold, Spoon, Bettencourt, Sayre, Vojvodic, Skarlatos, Gordon, Ebert, Kwak, Moyé, Simari.
Statistical analysis: Traverse, Lai, Gee, Baraniuk, Kwak, Moyé.
Obtained funding: Traverse, Willerson, Hatzopoulos, Penn, Vaughan, Piller, Simpson, Simari.
Administrative, technical, or material support: Traverse, Pepine, Willerson, Forder, Anderson, Penn, Raveendran, Lambert, Lerman, Gee, Taylor, Thomas, Olson, Bowman, Francescon, Geither, Handberg, Westbrook, Piller, Simpson, Loghin, Aguilar, Bettencourt, Sayre, Vojvodic, Skarlatos, Gordon, Ebert, Simari.
Study supervision: Traverse, Ellis, Forder, Penn, Perin, Chambers, Raveendran, Lambert, Lerman, Simon, Thomas, Simpson, Kwak, Simari.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Henry reported serving as a consultant for Capricor; and receiving grant funding from Capricor and Osiris. Dr Pepine reported receiving funding for writing assistance, medicines, equipment, or administrative support from the National, Heart, Lung and Blood Institute (NHLBI) and Biosafe. Dr Willerson reported receiving funding from the NHLBI for participation in review activities. Dr Ellis reported receiving travel support from Abbott Vascular and Boston Scientific. Dr Hatzopoulos reported receiving funding from the NHLBI for writing and reviewing manuscripts, and participating in review activities. Dr Penn reported serving as a consultant to Aastrom and Juventas; receiving grant funding from Athersys; and having patents, receiving royalties, and owning stock/stock options in Juventas Therapeutics; and receiving reimbursement for travel expenses from Juventas Therapeutics. Dr Perin reported serving as a consultant to Cytori, Celgene, Biosense Webster, and Cephalon. Dr Simon reported serving as a consultant to Cordis/Johnson & Johnson, Medtronic Vascular, Merck, the Medicines Company, and Portola; serving as an expert witness for Cordis/Johnson & Johnson; and receiving payment for lectures from Abbott Vascular. Dr Taylor reported receiving payment for lectures from the American Heart Association. Dr Thomas reported that he served as president of the American Society of Echocardiography in 2011-2012; and received grant funding from the National Space Biomedical Research Institute/National Aeronautics and Space Administration. Dr Handberg reported receiving grant funding from Amorcyte, Baxter, and BDI Pharma. Ms Westbrook reported receiving travel reimbursement from Barnett International. All of the authors reported receiving research grant funding and support for travel expenses to meetings for the Cardiovascular Cell Therapy Research Network from the NHLBI.
Funding/Support: Funding for this trial was provided by the National Heart, Lung, and Blood Institute under cooperative agreement 5 U01 HL087318-04.
Role of the Sponsor: The funding 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 of this manuscript. The funding sponsor reviewed and approved the manuscript.
National, Heart, Lung and Blood Institute (NHLBI) Project Office Team: Sonia Skarlatos, PhD, David Gordon, MD, PhD, Ray Ebert, PhD, Wendy Taddei-Peters, PhD, Min Jung Kwak, PhD, and Beckie Chamberlin.
Cardiovascular Cell Therapy Research Network (CCTRN) Steering Committee Chair: Robert Simari, MD.
Timing In Myocardial infarction Evaluation (TIME) Trial Investigators and Clinical Teams:Minneapolis Heart Institute Foundation: Timothy Henry, MD, Jay Traverse, MD, David McKenna, MD, Beth Jorgenson, RN, and Rachel Olson, RN, MS. Cleveland Clinic Foundation: Stephen Ellis, MD, Marc Penn, MD, PhD, Saif Anwaruddin, MD, James Harvey, MD, Jane Reese Koc, MT, Carrie Geither, RN, Mark Jarosz, RN, and Cindy Oblak. Texas Heart Institute: James Willerson, MD, Emerson Perin, MD, PhD, Guilherme Silva, MD, James Chen, RN, Casey Kappenman, Deirdre Smith, RN, and Lynette Westbrook, RN, MS. University of Florida Department of Medicine: Carl Pepine, MD, Barry Byrne, MD, David Anderson, PhD, MD, John Wingard, MD, Eileen Handberg, PhD, Tempa Curry, RN, and Diann Fisk, MT. Vanderbilt University School of Medicine: David Zhao, MD, Antonis Hatzopoulos, PhD, Allen Naftilan, MD, Sherry Bowman, RN, Judy Francescon, RN, and Karen Prater. St Paul Heart Clinic, United Hospital: Ken Baran, MD, and Jody LaRock, RN. Metropolitan Heart and Vascular Institute, Mercy Hospital: Jeffrey Chambers, MD, and Betty Hargan, RN. University of Minnesota: Ganesh Raveendran, MD, Emily Caldwell, RN, and Barb Bruhn-Ding, RN. University Hospitals Case Medical Center: Daniel Simon, MD, Marco Costa, MD, and Stacey Mazzurco, RN. Florida Hospital Pepin Heart Institute: Charles Lambert, MD, PhD, and Elizabeth Szymanski, RN. Mayo Clinic: Amir Lerman, MD, and Kelly Noonan, RN. Michael E. DeBakey Medical Center: Biswajit Kar, MD.
Data Coordinating Center and Laboratory Teams:University of Texas School of Public Health: Lemuel Moyé, MD, PhD, Dejian Lai, PhD, Linda Piller, MD, MPH, Lara Simpson, PhD, Sarah Baraniuk, PhD, Shreela Sharma, PhD, Judy Bettencourt, MPH, Shelly Sayre, MPH, Rachel Vojvodic, MPH, Larry Cormier, Robert Brown, PhD, Diane Eady, Kristen Lucas, MS, Sibi Mathew, and Michelle Cohen, MPH. Baylor College of Medicine: Adrian Gee, PhD, Sara Richman, David Aguilar, MD. University of Texas Medical School: Catalin Loghin, MD. University of Florida Department of Medicine: John Forder, PhD (MRI Core Laboratory), Christopher R. Cogle, MD, and Elizabeth Wise (Biorepository Core-Florida). Cleveland Clinic C5 Research Imaging Core: James Thomas, MD, Allen Borowski, Annitta Flinn, and Cathy McDowell (Echo Core Laboratory). Center for Cardiovascular Repair: Doris Taylor, PhD, Claudia Zierold, PhD, and Marjorie Carlson (Biorepository Core-Minnesota).
Additional Contributions: The CCTRN acknowledges its industry partners Biosafe and Boston Scientific Corporation for contributions of equipment and technical support during the conduct of the trial. We thank the NHLBI gene and cell therapies data and safety monitoring board and the NHLBI protocol review committee for their review and guidance of the LateTIME trial.
This article was corrected for errors on December 28, 2012 and June 11, 2015.