Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

NCT00761787 | Completed

• 1 other identifier: CARGO II
• Study Type: observational
• Target: 800
• Locations: 11 countries
• Sites: 17

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.

Conditions

Graft Rejection; Heart Disease

Keywords

allograft; rejection; biopsy; gene; expression; cardiology; heart; transplant

Outcome Measures

Primary Outcomes (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.

  Scheduled clinic visit

Secondary Outcomes (2)

• 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

Study Arms (1)

1

Heart transplanted subjects.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

New and existing cardiac allograft recipients.

You may qualify if:

• New and existing allograft recipients
• All patients (age ≥ 18years) receiving post-transplant care at the enrolling centers

You may not qualify if:

• Concurrent enrollment in a double-blind drug trial (immunosuppressive drugs).

Sponsors & Collaborators

• XDx: lead

Study Sites (17)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

Medizinische Universität Innsbruck, Klinische Abteilung für Herzchirurgie

Anichstrasse 35, Innsbruck, A-6020, Austria

Location

Medical University of Vienna (Medizinische Universität Wien)

Währinger Gürtel 18-20, Vienna, 1090, Austria

Location

UZ Gasthuisberg

Herestraat 49, Leuven, 3000, Belgium

Location

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Hospital La Pitie

47 Bd de L, Paris, 75013, France

Location

Herz- und Diabeteszentrum NRW

Georgstraße 11, Bad Oeynhausen, D-32545, Germany

Location

Medizinische Hochschule Hannover

Hanover, Carl-Neuberg-Str. 1, 30625, Germany

Location

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

Albert-Schweitzer-Str. 33, Münster, D-48149, Germany

Location

Deutsches Herzzentrum Berlin

Augustenburger Platz, State of Berlin, 13353, Germany

Location

Ospedali Riuniti di Bergamo

Largo Barozzi 1, Bergamo, 24128, Italy

Location

Silesian Center for Heart Disease

Ul. Szpitalna 2, Zabrze, 41-800, Poland

Location

Hospital Juan Canalejo

As Xubias 84, La Coruna, 15006, Spain

Location

Inselspital - Universitätsspital Bern Postfach 33

Schweizer Herz-und Gefässzentrum Bern, Canton of Bern, 3010, Switzerland

Location

Papworth Hospital

Papworth Everard, Cambridge, CB3 8RE, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 26746629 DERIVED

• 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.

  PMID: 26452346 DERIVED

• 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.

  PMID: 23222738 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood whole blood white blood cells

MeSH Terms

Conditions

Heart Diseases; Rejection, Psychology

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Social Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: May 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: March 9, 2009

Record last verified: 2009-03

Locations

BE (1); CA (1); FR (1); ES (1); US (3); AU (2); CH (1); PL (1); IT (1); DE (4); GB (1)