Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

Heart Disease Clinical Trial

— CARGOII  

Official title:

Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761787
• Other study ID #: CARGO II
• Status: Completed
• Phase: N/A
• First received: September 26, 2008
• Last updated: March 5, 2009
• Start date: May 2005
• Est. completion date: February 2009

Study information

• Verified date: March 2009
• Source: XDx
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionBelgium: Institutional Review BoardCanada: Ethics Review CommitteeFrance: Institutional Ethical CommitteeGermany: Ethics CommissionItaly: Ethics CommitteeSpain: Ethics CommitteeSpain: Comité Ético de Investigación ClínicaSwitzerland: EthikkommissionUnited Kingdom: Research Ethics CommitteeUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Graft Rejection
• Heart Disease

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck, Klinische Abteilung für Herzchirurgie	Anichstrasse 35	Innsbruck
Austria	Medical University of Vienna (Medizinische Universität Wien)	Währinger Gürtel 18-20	Vienna
Belgium	UZ Gasthuisberg	Herestraat 49	Leuven
Canada	Toronto General Hospital	Toronto	Ontario
France	Hospital La Pitie	47 Bd de l	Paris
Germany	UKM - Medizinische Klinik und Poliklinik C (Kardiologie und Angiologie)	Albert-Schweitzer-Str. 33	Münster
Germany	Deutsches Herzzentrum Berlin	Augustenburger Platz	Berlin
Germany	Herz- und Diabeteszentrum NRW	Georgstraße 11	Bad Oeynhausen
Germany	Medizinische Hochschule Hannover	Hannover	Carl-Neuberg-Str. 1
Italy	Ospedali Riuniti di Bergamo	Largo Barozzi 1	Bergamo
Poland	Silesian Center for Heart Disease	ul. Szpitalna 2	Zabrze
Spain	Hospital Juan Canalejo	As Xubias 84	La Coruna
Switzerland	Inselspital - Universitätsspital Bern Postfach 33	Schweizer Herz-und Gefässzentrum Bern	Bern
United Kingdom	Papworth Hospital	Papworth Everard	Cambridge
United States	Texas Heart Institute	Houston	Texas
United States	University of Minnesota	Minneapolis	Minnesota
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
XDx

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Germany,  Italy,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No