Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

XDx800 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

800

Conditions

Graft Rejection Heart Disease

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (17)

University of Minnesota

Minneapolis, Minnesota, United States

Columbia University Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Scheduled clinic visit

Secondary Outcomes

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.

Time frame: 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.

Time frame: >2 months after date of transplant

Data from ClinicalTrials.gov

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