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

March 5, 2009 updated by: XDx
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

New and existing cardiac allograft recipients.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Heart transplanted subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Scheduled clinic visit

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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.
Time Frame: >2 months after date of transplant
>2 months after date of transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XDx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (Estimate)

September 30, 2008

Study Record Updates

Last Update Posted (Estimate)

March 9, 2009

Last Update Submitted That Met QC Criteria

March 5, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARGO II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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