NCT00761787|Completed
Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY
CARGOII
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CARGOII
Sponsor study identifier
observational
800
11 countries
17
Study Start
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2009
Actual (reported)Study Completion
February 2009
Actual (reported)The Cardiac Allograft Rejection Gene Expression Observational (CARGO) II Study is designed to provide independent evidence of the clinical performance of the non-invasive AlloMap test. Sensitive detection of cardiac allograft rejection and dysfunction is the basis for successful recipient management. The CARGO II Study will assess the correlation between the presence or absence of acute cellular rejection as determined by examination of endomyocardial biopsy specimens with results from the AlloMap Test. Of 17 participating transplant centers, 4 are in North America and 13 are in Europe.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 26, 2008
Actual (reported)September 30, 2008
Actual (reported)February 2009
Actual (reported)February 2009
Actual (reported)Acute Cellular Rejection(ACR)grades - ACR ISHLT Grades will be determined by centralized pathology reading. The associated AlloMap Test score will be correlated to the biopsy reading.
Scheduled clinic visit
Evaluation of the AlloMap Test and novel gene expression algorithm in guiding management of steroids and calcineurin inhibitors based on the algorithm's capacity to predict future cellular rejection and future graft dysfunction.
more than 2 months following date of transplant
Assessment of clinical utility of the AlloMap Test and novel gene expression algorithms in diagnosis and prediction of humoral rejection.
>2 months after date of transplant
Heart transplanted subjects.
New and existing cardiac allograft recipients.
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Columbia University Medical Center
New York, New York, 10032, United States
Texas Heart Institute
Houston, Texas, 77030, United States
Medizinische Universität Innsbruck, Klinische Abteilung für Herzchirurgie
Anichstrasse 35, Innsbruck, A-6020, Austria
Medical University of Vienna (Medizinische Universität Wien)
Währinger Gürtel 18-20, State of Vienna, 1090, Austria
UZ Gasthuisberg
Herestraat 49, Leuven, 3000, Belgium
Toronto General Hospital
Crespo-Leiro MG, Stypmann J, Schulz U, Zuckermann A, Mohacsi P, Bara C, Ross H, Parameshwar J, Zakliczynski M, Fiocchi R, Hoefer D, Colvin M, Deng MC, Leprince P, Elashoff B, Yee JP, Vanhaecke J. Clinical usefulness of gene-expression profile to rule out acute rejection after heart transplantation: CARGO II. Eur Heart J. 2016 Sep 1;37(33):2591-601. doi: 10.1093/eurheartj/ehv682. Epub 2016 Jan 7.
Crespo-Leiro MG, Stypmann J, Schulz U, Zuckermann A, Mohacsi P, Bara C, Ross H, Parameshwar J, Zakliczynski M, Fiocchi R, Hoefer D, Deng M, Leprince P, Hiller D, Eubank L, Deljkich E, Yee JP, Vanhaecke J. Performance of gene-expression profiling test score variability to predict future clinical events in heart transplant recipients. BMC Cardiovasc Disord. 2015 Oct 9;15:120. doi: 10.1186/s12872-015-0106-1.
venous blood whole blood white blood cells
First Submitted
September 26, 2008
First Posted
September 30, 2008
Study Start
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2009
Actual (reported)Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels
Contact the study team to confirm eligibility.
Toronto, Ontario, M5G 2N2, Canada
Hospital La Pitie
47 Bd de L, Paris, 75013, France
Herz- und Diabeteszentrum NRW
Georgstraße 11, Bad Oeynhausen, D-32545, Germany
Medizinische Hochschule Hannover
Hanover, Carl-Neuberg-Str. 1, 30625, Germany
UKM - Medizinische Klinik und Poliklinik C (Kardiologie und Angiologie)
Albert-Schweitzer-Str. 33, Münster, D-48149, Germany
Deutsches Herzzentrum Berlin
Augustenburger Platz, State of Berlin, 13353, Germany
Ospedali Riuniti di Bergamo
Largo Barozzi 1, Bergamo, 24128, Italy
Silesian Center for Heart Disease
Ul. Szpitalna 2, Zabrze, 41-800, Poland
Hospital Juan Canalejo
As Xubias 84, La Coruna, 15006, Spain
Inselspital - Universitätsspital Bern Postfach 33
Schweizer Herz-und Gefässzentrum Bern, Canton of Bern, 3010, Switzerland
Papworth Hospital
Papworth Everard, Cambridge, CB3 8RE, United Kingdom
Crespo-Leiro MG, Zuckermann A, Bara C, Mohacsi P, Schulz U, Boyle A, Ross HJ, Parameshwar J, Zakliczynski M, Fiocchi R, Stypmann J, Hoefer D, Lehmkuhl H, Deng MC, Leprince P, Berry G, Marboe CC, Stewart S, Tazelaar HD, Baron HM, Coleman IC, Vanhaecke J. Concordance among pathologists in the second Cardiac Allograft Rejection Gene Expression Observational Study (CARGO II). Transplantation. 2012 Dec 15;94(11):1172-7. doi: 10.1097/TP.0b013e31826e19e2.
Study Completion
February 2009
Actual (reported)Last Updated
March 9, 2009
Record last verified: 2009-03
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