Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

NCT ID: NCT00761787

Last Updated: 2009-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2009-02-28

Brief Summary

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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

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Conditions

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Graft Rejection Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Heart transplanted subjects.

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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XDx

INDUSTRY

Sponsor Role lead

Responsible Party

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XDx, Inc.

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Texas Heart Institute

Houston, Texas, United States

Site Status

Medizinische Universität Innsbruck, Klinische Abteilung für Herzchirurgie

Anichstrasse 35, Innsbruck, Austria

Site Status

Medical University of Vienna (Medizinische Universität Wien)

Währinger Gürtel 18-20, Vienna, Austria

Site Status

UZ Gasthuisberg

Herestraat 49, Leuven, Belgium

Site Status

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Hospital La Pitie

47 Bd de L, Paris, France

Site Status

Herz- und Diabeteszentrum NRW

Georgstraße 11, Bad Oeynhausen, Germany

Site Status

Medizinische Hochschule Hannover

Hanover, Carl-Neuberg-Str. 1, Germany

Site Status

UKM - Medizinische Klinik und Poliklinik C (Kardiologie und Angiologie)

Albert-Schweitzer-Str. 33, Münster, Germany

Site Status

Deutsches Herzzentrum Berlin

Augustenburger Platz, State of Berlin, Germany

Site Status

Ospedali Riuniti di Bergamo

Largo Barozzi 1, Bergamo, Italy

Site Status

Silesian Center for Heart Disease

Ul. Szpitalna 2, Zabrze, Poland

Site Status

Hospital Juan Canalejo

As Xubias 84, La Coruna, Spain

Site Status

Inselspital - Universitätsspital Bern Postfach 33

Schweizer Herz-und Gefässzentrum Bern, Canton of Bern, Switzerland

Site Status

Papworth Hospital

Papworth Everard, Cambridge, United Kingdom

Site Status

Countries

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

References

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Crespo-Leiro MG, Stypmann J, Schulz U, Zuckermann A, Mohacsi P, Bara C, Ross H, Parameshwar J, Zakliczynski M, Fiocchi R, Hoefer D, Colvin M, Deng MC, Leprince P, Elashoff B, Yee JP, Vanhaecke J. Clinical usefulness of gene-expression profile to rule out acute rejection after heart transplantation: CARGO II. Eur Heart J. 2016 Sep 1;37(33):2591-601. doi: 10.1093/eurheartj/ehv682. Epub 2016 Jan 7.

Reference Type DERIVED
PMID: 26746629 (View on PubMed)

Crespo-Leiro MG, Stypmann J, Schulz U, Zuckermann A, Mohacsi P, Bara C, Ross H, Parameshwar J, Zakliczynski M, Fiocchi R, Hoefer D, Deng M, Leprince P, Hiller D, Eubank L, Deljkich E, Yee JP, Vanhaecke J. Performance of gene-expression profiling test score variability to predict future clinical events in heart transplant recipients. BMC Cardiovasc Disord. 2015 Oct 9;15:120. doi: 10.1186/s12872-015-0106-1.

Reference Type DERIVED
PMID: 26452346 (View on PubMed)

Crespo-Leiro MG, Zuckermann A, Bara C, Mohacsi P, Schulz U, Boyle A, Ross HJ, Parameshwar J, Zakliczynski M, Fiocchi R, Stypmann J, Hoefer D, Lehmkuhl H, Deng MC, Leprince P, Berry G, Marboe CC, Stewart S, Tazelaar HD, Baron HM, Coleman IC, Vanhaecke J. Concordance among pathologists in the second Cardiac Allograft Rejection Gene Expression Observational Study (CARGO II). Transplantation. 2012 Dec 15;94(11):1172-7. doi: 10.1097/TP.0b013e31826e19e2.

Reference Type DERIVED
PMID: 23222738 (View on PubMed)

Other Identifiers

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CARGO II

Identifier Type: -

Identifier Source: org_study_id

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