Literature DB >> 23588961

Phase II clinical research design in cardiology: learning the right lessons too well: observations and recommendations from the Cardiovascular Cell Therapy Research Network (CCTRN).

Joshua M Hare1, Roberto Bolli, John P Cooke, David J Gordon, Timothy D Henry, Emerson C Perin, Keith L March, Michael P Murphy, Carl J Pepine, Robert D Simari, Sonia I Skarlatos, Jay H Traverse, James T Willerson, Anita D Szady, Doris A Taylor, Rachel W Vojvodic, Phillip C Yang, Lemuel A Moyé.   

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Year:  2013        PMID： 23588961      PMCID： PMC3967793          DOI： 10.1161/CIRCULATIONAHA.112.000779

Source DB:  PubMed          Journal:  Circulation        ISSN： 0009-7322            Impact factor:   29.690


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  28 in total

Review 1.  Trials within trials: confirmatory subgroup analyses in controlled clinical experiments.

Authors:  L A Moyé; A Deswal
Journal:  Control Clin Trials       Date:  2001-12

2.  Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure: randomised trial--the Losartan Heart Failure Survival Study ELITE II.

Authors:  B Pitt; P A Poole-Wilson; R Segal; F A Martinez; K Dickstein; A J Camm; M A Konstam; G Riegger; G H Klinger; J Neaton; D Sharma; B Thiyagarajan
Journal:  Lancet       Date:  2000-05-06       Impact factor: 79.321

3.  Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).

Authors: 
Journal:  JAMA       Date:  2002-12-18       Impact factor: 56.272

4.  Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction.

Authors: 
Journal:  N Engl J Med       Date:  1989-08-10       Impact factor: 91.245

5.  Effects of the angiotensin converting enzyme inhibitor enalapril on the long-term progression of left ventricular dysfunction in patients with heart failure. SOLVD Investigators.

Authors:  M A Konstam; M F Rousseau; M W Kronenberg; J E Udelson; J Melin; D Stewart; N Dolan; T R Edens; S Ahn; D Kinan
Journal:  Circulation       Date:  1992-08       Impact factor: 29.690

6.  Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials.

Authors:  S Yusuf; J Wittes; J Probstfield; H A Tyroler
Journal:  JAMA       Date:  1991-07-03       Impact factor: 56.272

7.  Five-year findings of the hypertension detection and follow-up program. I. Reduction in mortality of persons with high blood pressure, including mild hypertension. Hypertension Detection and Follow-up Program Cooperative Group.

Authors: 
Journal:  JAMA       Date:  1979-12-07       Impact factor: 56.272

8.  Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. Results of the survival and ventricular enlargement trial. The SAVE Investigators.

Authors:  M A Pfeffer; E Braunwald; L A Moyé; L Basta; E J Brown; T E Cuddy; B R Davis; E M Geltman; S Goldman; G C Flaker
Journal:  N Engl J Med       Date:  1992-09-03       Impact factor: 91.245

9.  Effect of the use and timing of bone marrow mononuclear cell delivery on left ventricular function after acute myocardial infarction: the TIME randomized trial.

Authors:  Jay H Traverse; Timothy D Henry; Carl J Pepine; James T Willerson; David X M Zhao; Stephen G Ellis; John R Forder; R David Anderson; Antonis K Hatzopoulos; Marc S Penn; Emerson C Perin; Jeffrey Chambers; Kenneth W Baran; Ganesh Raveendran; Charles Lambert; Amir Lerman; Daniel I Simon; Douglas E Vaughan; Dejian Lai; Adrian P Gee; Doris A Taylor; Christopher R Cogle; James D Thomas; Rachel E Olson; Sherry Bowman; Judy Francescon; Carrie Geither; Eileen Handberg; Casey Kappenman; Lynette Westbrook; Linda B Piller; Lara M Simpson; Sarah Baraniuk; Catalin Loghin; David Aguilar; Sara Richman; Claudia Zierold; Daniel B Spoon; Judy Bettencourt; Shelly L Sayre; Rachel W Vojvodic; Sonia I Skarlatos; David J Gordon; Ray F Ebert; Minjung Kwak; Lemuel A Moyé; Robert D Simari
Journal:  JAMA       Date:  2012-12-12       Impact factor: 56.272

10.  Multiple risk factor intervention trial. Risk factor changes and mortality results. Multiple Risk Factor Intervention Trial Research Group.

Authors: 
Journal:  JAMA       Date:  1982-09-24       Impact factor: 56.272
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  20 in total

1.  Clinical research skills development program in cell-based regenerative medicine.

Authors:  Ivonne Hernandez Schulman; Viky Suncion; Vasileios Karantalis; Wayne Balkan; Joshua M Hare
Journal:  Stem Cells Transl Med       Date:  2014-12-29       Impact factor: 6.940

Review 2.  A critical analysis of clinical outcomes reported in stem cell trials for acute myocardial infarction: some thoughts for design of future trials.

Authors:  Anita D Szady; Carl J Pepine; Shreela V Sharma; Christopher R Cogle; Emerson C Perin; Stephen G Ellis; Lemuel A Moyé
Journal:  Curr Atheroscler Rep       Date:  2013-08       Impact factor: 5.113

3.  Rationale and Design of the CONCERT-HF Trial (Combination of Mesenchymal and c-kit+ Cardiac Stem Cells As Regenerative Therapy for Heart Failure).

Authors:  Roberto Bolli; Joshua M Hare; Keith L March; Carl J Pepine; James T Willerson; Emerson C Perin; Phillip C Yang; Timothy D Henry; Jay H Traverse; Raul D Mitrani; Aisha Khan; Ivonne Hernandez-Schulman; Doris A Taylor; Darcy L DiFede; João A C Lima; Atul Chugh; John Loughran; Rachel W Vojvodic; Shelly L Sayre; Judy Bettencourt; Michelle Cohen; Lem Moyé; Ray F Ebert; Robert D Simari
Journal:  Circ Res       Date:  2018-04-27       Impact factor: 17.367

4.  Rationale and design for PACE: patients with intermittent claudication injected with ALDH bright cells.

Authors:  Emerson C Perin; Michael Murphy; John P Cooke; Lem Moyé; Timothy D Henry; Judy Bettencourt; Amir Gahremanpour; Nicholas Leeper; R David Anderson; William R Hiatt; Joao A Lima; Bharath Venkatesh; Shelly L Sayre; Rachel W Vojvodic; Doris A Taylor; Ray F Ebert; Alan T Hirsch
Journal:  Am Heart J       Date:  2014-07-30       Impact factor: 4.749

5.  Rationale and Design of the SENECA (StEm cell iNjECtion in cAncer survivors) Trial.

Authors:  Roberto Bolli; Joshua M Hare; Timothy D Henry; Carrie G Lenneman; Keith L March; Kathy Miller; Carl J Pepine; Emerson C Perin; Jay H Traverse; James T Willerson; Phillip C Yang; Adrian P Gee; João A Lima; Lem Moyé; Rachel W Vojvodic; Shelly L Sayre; Judy Bettencourt; Michelle Cohen; Ray F Ebert; Robert D Simari
Journal:  Am Heart J       Date:  2018-04-04       Impact factor: 4.749

6.  Evaluation of Cell Therapy on Exercise Performance and Limb Perfusion in Peripheral Artery Disease: The CCTRN PACE Trial (Patients With Intermittent Claudication Injected With ALDH Bright Cells).

Authors:  Emerson C Perin; Michael P Murphy; Keith L March; Roberto Bolli; John Loughran; Phillip C Yang; Nicholas J Leeper; Ronald L Dalman; Jason Alexander; Timothy D Henry; Jay H Traverse; Carl J Pepine; R David Anderson; Scott Berceli; James T Willerson; Raja Muthupillai; Amir Gahremanpour; Ganesh Raveendran; Omaida Velasquez; Joshua M Hare; Ivonne Hernandez Schulman; Vijaykumar S Kasi; William R Hiatt; Bharath Ambale-Venkatesh; João A Lima; Doris A Taylor; Micheline Resende; Adrian P Gee; April G Durett; Jeanette Bloom; Sara Richman; Patricia G'Sell; Shari Williams; Fouzia Khan; Elsie Gyang Ross; Michelle R Santoso; JoAnne Goldman; Dana Leach; Eileen Handberg; Benjamin Cheong; Nichole Piece; Darcy DiFede; Barb Bruhn-Ding; Emily Caldwell; Judy Bettencourt; Dejian Lai; Linda Piller; Lara Simpson; Michelle Cohen; Shelly L Sayre; Rachel W Vojvodic; Lem Moyé; Ray F Ebert; Robert D Simari; Alan T Hirsch
Journal:  Circulation       Date:  2017-02-16       Impact factor: 29.690

7.  Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: the TAC-HFT randomized trial.

Authors:  Alan W Heldman; Darcy L DiFede; Joel E Fishman; Juan P Zambrano; Barry H Trachtenberg; Vasileios Karantalis; Muzammil Mushtaq; Adam R Williams; Viky Y Suncion; Ian K McNiece; Eduard Ghersin; Victor Soto; Gustavo Lopera; Roberto Miki; Howard Willens; Robert Hendel; Raul Mitrani; Pradip Pattany; Gary Feigenbaum; Behzad Oskouei; John Byrnes; Maureen H Lowery; Julio Sierra; Mariesty V Pujol; Cindy Delgado; Phillip J Gonzalez; Jose E Rodriguez; Luiza Lima Bagno; Didier Rouy; Peter Altman; Cheryl Wong Po Foo; Jose da Silva; Erica Anderson; Richard Schwarz; Adam Mendizabal; Joshua M Hare
Journal:  JAMA       Date:  2014-01-01       Impact factor: 56.272

Review 8.  Position Paper of the European Society of Cardiology Working Group Cellular Biology of the Heart: cell-based therapies for myocardial repair and regeneration in ischemic heart disease and heart failure.

Authors:  Rosalinda Madonna; Linda W Van Laake; Sean M Davidson; Felix B Engel; Derek J Hausenloy; Sandrine Lecour; Jonathan Leor; Cinzia Perrino; Rainer Schulz; Kirsti Ytrehus; Ulf Landmesser; Christine L Mummery; Stefan Janssens; James Willerson; Thomas Eschenhagen; Péter Ferdinandy; Joost P G Sluijter
Journal:  Eur Heart J       Date:  2016-04-07       Impact factor: 29.983

Review 9.  Endpoints in stem cell trials in ischemic heart failure.

Authors:  Marko Banovic; Zlatibor Loncar; Atta Behfar; Marc Vanderheyden; Branko Beleslin; Andreas Zeiher; Marco Metra; Andre Terzic; Jozef Bartunek
Journal:  Stem Cell Res Ther       Date:  2015-08-29       Impact factor: 6.832

Review 10.  Translating stem cell research to cardiac disease therapies: pitfalls and prospects for improvement.

Authors:  Michael R Rosen; Robert J Myerburg; Darrel P Francis; Graham D Cole; Eduardo Marbán
Journal:  J Am Coll Cardiol       Date:  2014-09-02       Impact factor: 24.094
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