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Completed

NCT Number: NCT00761787

Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

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.

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Key information

Conditions

Graft Rejection Behavior Cardiovascular Diseases Heart Disease Heart Diseases Rejection, Psychology Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Innsbruck, Klinische Abteilung für Herzchirurgie, Anichstrasse 35, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

XDx

Industry

Registry information

Acronym: CARGOII

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 30, 2008
Registry last updated
Mar 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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