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Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY (CARGOII)

This study has been completed.
Sponsor:
Information provided by:
XDx
ClinicalTrials.gov Identifier:
NCT00761787
First received: September 26, 2008
Last updated: March 5, 2009
Last verified: March 2009
  Purpose

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.


Condition
Graft Rejection
Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

Resource links provided by NLM:


Further study details as provided by XDx:

Primary Outcome Measures:
  • 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. [ Time Frame: Scheduled clinic visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: more than 2 months following date of transplant ] [ Designated as safety issue: No ]
  • Assessment of clinical utility of the AlloMap Test and novel gene expression algorithms in diagnosis and prediction of humoral rejection. [ Time Frame: >2 months after date of transplant ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

venous blood whole blood white blood cells


Estimated Enrollment: 800
Study Start Date: May 2005
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Heart transplanted subjects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

New and existing cardiac allograft recipients.

Criteria

Inclusion Criteria:

  • New and existing allograft recipients
  • All patients (age ≥ 18years) receiving post-transplant care at the enrolling centers

Exclusion Criteria:

  • Concurrent enrollment in a double-blind drug trial (immunosuppressive drugs).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761787

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Texas
Texas Heart Institute
Houston, Texas, United States, 77030
Austria
Medizinische Universität Innsbruck, Klinische Abteilung für Herzchirurgie
Anichstrasse 35, Innsbruck, Austria, A-6020
Medical University of Vienna (Medizinische Universität Wien)
Währinger Gürtel 18-20, Vienna, Austria, 1090
Belgium
UZ Gasthuisberg
Herestraat 49, Leuven, Belgium, 3000
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
France
Hospital La Pitie
47 Bd de l, Paris, France, 75013
Germany
Herz- und Diabeteszentrum NRW
Georgstraße 11, Bad Oeynhausen, Germany, D-32545
Deutsches Herzzentrum Berlin
Augustenburger Platz, Berlin, Germany, 13353
Medizinische Hochschule Hannover
Hannover, Carl-Neuberg-Str. 1, Germany, 30625
UKM - Medizinische Klinik und Poliklinik C (Kardiologie und Angiologie)
Albert-Schweitzer-Str. 33, Münster, Germany, D-48149
Italy
Ospedali Riuniti di Bergamo
Largo Barozzi 1, Bergamo, Italy, 24128
Poland
Silesian Center for Heart Disease
ul. Szpitalna 2, Zabrze, Poland, 41-800
Spain
Hospital Juan Canalejo
As Xubias 84, La Coruna, Spain, 15006
Switzerland
Inselspital - Universitätsspital Bern Postfach 33
Schweizer Herz-und Gefässzentrum Bern, Bern, Switzerland, 3010
United Kingdom
Papworth Hospital
Papworth Everard, Cambridge, United Kingdom, CB3 8RE
Sponsors and Collaborators
XDx
  More Information

No publications provided by XDx

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helen Baron, MD Associate Medical Director, XDx, Inc.
ClinicalTrials.gov Identifier: NCT00761787     History of Changes
Other Study ID Numbers: CARGO II
Study First Received: September 26, 2008
Last Updated: March 5, 2009
Health Authority: Austria: Ethikkommission
Belgium: Institutional Review Board
Canada: Ethics Review Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Italy: Ethics Committee
Spain: Ethics Committee
Spain: Comité Ético de Investigación Clínica
Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee
United States: Institutional Review Board

Keywords provided by XDx:
allograft
rejection
biopsy
gene
expression
cardiology
heart
transplant

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014