Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Heart transplanted subjects. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
New and existing cardiac allograft recipients.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| Columbia University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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, 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. | |
| 26452346 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
venous blood whole blood white blood cells
| >2 months after date of transplant |
| New York |
| New York |
| 10032 |
| United States |
| Texas Heart Institute | Houston | Texas | 77030 | United States |
| Medizinische Universität Innsbruck, Klinische Abteilung für Herzchirurgie | Anichstrasse 35 | Innsbruck | A-6020 | Austria |
| Medical University of Vienna (Medizinische Universität Wien) | Währinger Gürtel 18-20 | State of Vienna | 1090 | Austria |
| UZ Gasthuisberg | Herestraat 49 | Leuven | 3000 | Belgium |
| Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| Hospital La Pitie | 47 Bd de L | Paris | 75013 | France |
| Herz- und Diabeteszentrum NRW | Georgstraße 11 | Bad Oeynhausen | D-32545 | Germany |
| Medizinische Hochschule Hannover | Hanover | Carl-Neuberg-Str. 1 | 30625 | Germany |
| UKM - Medizinische Klinik und Poliklinik C (Kardiologie und Angiologie) | Albert-Schweitzer-Str. 33 | Münster | D-48149 | Germany |
| Deutsches Herzzentrum Berlin | Augustenburger Platz | State of Berlin | 13353 | Germany |
| Ospedali Riuniti di Bergamo | Largo Barozzi 1 | Bergamo | 24128 | Italy |
| Silesian Center for Heart Disease | Ul. Szpitalna 2 | Zabrze | 41-800 | Poland |
| Hospital Juan Canalejo | As Xubias 84 | La Coruna | 15006 | Spain |
| Inselspital - Universitätsspital Bern Postfach 33 | Schweizer Herz-und Gefässzentrum Bern | Canton of Bern | 3010 | Switzerland |
| Papworth Hospital | Papworth Everard | Cambridge | CB3 8RE | United Kingdom |
| 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. |
| 23222738 | 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. |