Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY (CARGOII)

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Status: Completed

Conditions: Graft Rejection; Heart Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT00761787

CARGO II

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

800 participants in 1 patient group

1

Description:

Heart transplanted subjects.