Document Detail


Integrating ancillary studies in a large clinical trial: the design and rationale of the APEX library.
MedLine Citation:
PMID:  18644468     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The APEX library was a coordinated and integrated set of ancillary analyses and substudies that were a part of the large APEX-AMI trial. The library included electrocardiogram, angiographic, blood biomarker, genetics, and MRI components. Operationally, the goals and administration of the APEX library were developed concurrently with the design of the parent trial. The goal recruitment in the library was met due to this approach. These data will provide important insights into the pathobiology of acute myocardial infarction and the relationships between inflammation, thrombosis, genetics, and classic clinical markers from angiograms, electrocardiograms, and patient demographics. In conclusion, the APEX library is an example of successful collaboration among academic trial leaders, site investigators, and pharmaceutical sponsors. The operational paradigm of this effort should be considered in future investigations so that important advances in clinical care of disease can be realized efficiently.
Authors:
Kenneth W Mahaffey; Craig J Reist; Yuling Fu; Sorin J Brener; Pierre Theroux; Manesh R Patel; Amanda Stebbins; Cynthia M Westerhout; Thomas G Todaro; Peter X Adams; Christopher B Granger; Paul W Armstrong;
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2008-07-01
Journal Detail:
Title:  Contemporary clinical trials     Volume:  29     ISSN:  1559-2030     ISO Abbreviation:  -     Publication Date:  2008 Nov 
Date Detail:
Created Date:  2008-10-22     Completed Date:  2009-02-12     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101242342     Medline TA:  Contemp Clin Trials     Country:  United States    
Other Details:
Languages:  eng     Pagination:  887-95     Citation Subset:  IM    
Affiliation:
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA. mahaf002@mc.duke.edu
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MeSH Terms
Descriptor/Qualifier:
Angioplasty, Transluminal, Percutaneous Coronary
Antibodies, Monoclonal / pharmacology,  therapeutic use*
Biological Markers
Biomedical Research / methods*
Clinical Trials as Topic*
Coronary Thrombosis
Double-Blind Method
Humans
Inflammation
Magnetic Resonance Imaging
Multicenter Studies as Topic*
Myocardial Reperfusion / methods
Research Design*
Chemical
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Biological Markers; 0/h5G1.1-scFv
Investigator
Investigator/Affiliation:
Paul W Armstrong / ; Yuling Fu / ; Corina Boyd / ; Sorin Brener / ; Christopher B Granger / ; Kenneth W Mahaffey / ; Pierre Theroux / ; Manesh R Patel / ; Raymond J Kim / ; Robert Judd / ; Steven Worthley / ; Frank Rademakers / ; Gilbert L Raff / ; Uma S Valeti / ; Thorsten Dill /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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