Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00761787

Acronym

CARGOII

Enrollment

800

Registered

2008-09-30

Start date

2005-05-31

Completion date

2009-02-28

Last updated

2009-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Rejection, Heart Disease

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	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

Secondary

Measure	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.	>2 months after date of transplant

Countries

Austria, Belgium, Canada, France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom, United States

Outcome results