Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

Completed

• Conditions: Graft Rejection; Heart Disease

• Registration Number: NCT00761787
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-05
• Last Update Posted: 2009-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (17)

Medical University of Vienna (Medizinische Universität Wien); 🇦🇹 Währinger Gürtel 18-20, Vienna, Austria

Silesian Center for Heart Disease; 🇵🇱 ul. Szpitalna 2, Zabrze, Poland

Inselspital - Universitätsspital Bern Postfach 33; 🇨🇭 Schweizer Herz-und Gefässzentrum Bern, Bern, Switzerland

UZ Gasthuisberg; 🇧🇪 Herestraat 49, Leuven, Belgium

Medizinische Universität Innsbruck, Klinische Abteilung für Herzchirurgie; 🇦🇹 Anichstrasse 35, Innsbruck, Austria

Herz- und Diabeteszentrum NRW; 🇩🇪 Georgstraße 11, Bad Oeynhausen, Germany

Columbia University Medical Center; 🇺🇸 New York, New York, United States

UKM - Medizinische Klinik und Poliklinik C (Kardiologie und Angiologie); 🇩🇪 Albert-Schweitzer-Str. 33, Münster, Germany

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Hospital La Pitie; 🇫🇷 47 Bd de l, Paris, France

Deutsches Herzzentrum Berlin; 🇩🇪 Augustenburger Platz, Berlin, Germany

Hospital Juan Canalejo; 🇪🇸 As Xubias 84, La Coruna, Spain

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Carl-Neuberg-Str. 1, Germany

Ospedali Riuniti di Bergamo; 🇮🇹 Largo Barozzi 1, Bergamo, Italy

Papworth Hospital; 🇬🇧 Papworth Everard, Cambridge, United Kingdom

Texas Heart Institute; 🇺🇸 Houston, Texas, United States