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

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ClinicalTrials.gov Identifier: NCT00761787
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : March 9, 2009
Sponsor:
Information provided by:
XDx

Brief Summary:
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 or disease
Graft Rejection Heart Disease

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY
Study Start Date : May 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Group/Cohort
1
Heart transplanted subjects.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Biospecimen Retention:   Samples Without DNA
venous blood whole blood white blood cells


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761787


Locations
Show Show 17 study locations
Sponsors and Collaborators
XDx
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helen Baron, MD Associate Medical Director, XDx, Inc.
ClinicalTrials.gov Identifier: NCT00761787    
Other Study ID Numbers: CARGO II
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: March 9, 2009
Last Verified: March 2009
Keywords provided by XDx:
allograft
rejection
biopsy
gene
expression
cardiology
heart
transplant
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases