Clinical trial NCT00761787: Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY
Official title: Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graft Rejection
Heart Disease
Keywords: allograft
rejection
biopsy
gene
expression
cardiology
heart
transplant
Lead sponsor: XDx
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New and existing cardiac allograft recipients.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: Scheduled clinic visit
Secondary outcomes:
measure: 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.
timeFrame: more than 2 months following date of transplant
measure: Assessment of clinical utility of the AlloMap Test and novel gene expression algorithms in diagnosis and prediction of humoral rejection.
timeFrame: >2 months after date of transplant
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Anichstrasse 35
country: Austria
facility: Medizinische Universität Innsbruck, Klinische Abteilung für Herzchirurgie
state: Innsbruck
city: Währinger Gürtel 18-20
country: Austria
facility: Medical University of Vienna (Medizinische Universität Wien)
state: Vienna
city: Herestraat 49
country: Belgium
facility: UZ Gasthuisberg
state: Leuven
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: 47 Bd de l
country: France
facility: Hospital La Pitie
state: Paris
city: Georgstraße 11
country: Germany
facility: Herz- und Diabeteszentrum NRW
state: Bad Oeynhausen
city: Augustenburger Platz
country: Germany
facility: Deutsches Herzzentrum Berlin
state: Berlin
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Carl-Neuberg-Str. 1
city: Albert-Schweitzer-Str. 33
country: Germany
facility: UKM - Medizinische Klinik und Poliklinik C (Kardiologie und Angiologie)
state: Münster
city: Largo Barozzi 1
country: Italy
facility: Ospedali Riuniti di Bergamo
state: Bergamo
city: ul. Szpitalna 2
country: Poland
facility: Silesian Center for Heart Disease
state: Zabrze
city: As Xubias 84
country: Spain
facility: Hospital Juan Canalejo
state: La Coruna
city: Schweizer Herz-und Gefässzentrum Bern
country: Switzerland
facility: Inselspital - Universitätsspital Bern Postfach 33
state: Bern
city: Papworth Everard
country: United Kingdom
facility: Papworth Hospital
state: Cambridge
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.