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Completed

NCT Number: NCT01136135

Cardiac Magnetic Resonance Imaging (CMRI) for Detection of Cardiac Transplant Rejection

To find a non-invasive alternative (with using cardiac MRI) to invasive endomyocardial biopsies for serial detection (EMB) and follow-up of cellular rejection in heart transplant in childhood.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Necker

Paris, 75015, France

About this study

Objectives To find a non-invasive alternative (with using cardiac MRI) to invasive endomyocardial biopsies for serial detection and follow-up of cellular rejection in heart transplant in childhood.

Background Detection of cardiac rejection is a major problem in cardiac transplantation. Invasive screenings at predefined time intervals for cellular rejection with using endomyocardial biopsies are standard procedures. However, cardiac biopsies are distressing and risky and are also costly. Moreover, as the histological expression of allograft rejection is patchy, endomyocardial biopsies may lead to sampling error. Thus, as the sensitivity is low and variable (range for 40 to 95%), indication of biopsy is still of debate.

Materials and methods All patients who undergone cardiac transplant are potentially eligible. They will be prospectively included in the study. They will have both examinations, their routine endomyocardial biopsies and cardiac MRI. Histological diagnosis of cellular rejection is given by the BILLINGHAM classification which is used in daily practice. Diagnosis of rejection of cardiac MRI is defined by the association of hyperintensity on T2-weighted sequence, and on gadolinium-enhanced sequences including SSFP (study state free precession) and myocardial delayed enhancement. Both MRI parameters attest of the presence of myocardial oedema related to acute rejection. Myocardial oedema is also associated with segmental abnormalities of myocardial contraction which is assessed by both CMR-tagged sequence.

Written informed consent will be required from the patients. Institutional review board approval will also be required.

Expected results and clinical implications We expect to demonstrate that CMRI is effective for detection of cellular rejection with a high sensitivity (expected sensitivity>95%) as compared to cardiac biopsy. In that condition, cardiac MRI could replace the invasive biopsy for serial detection and follow-up of rejection in heart transplant.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • all patients who had undergone cardiac transplants are eligible

Exclusion criteria

  • no consent
  • allergy to contrast agent (Gadolinium)
  • severe renal failure (clearance < 30ml/min/1.73m²)
  • claustrophobia
  • severe arrhythmias
  • absence of medical care insurance
  • pregnancy

Treatment and study plan

Cardiac MRI

Other

To find a non-invasive alternative (with using cardiac MRI) to invasive endomyocardial biopsies for serial detection and follow-up of cellular rejection in heart transplant in childhood.

Primary outcomes

  1. The sensitivity and specificity of cardiac MRI for detecting heart transplant rejection will be calculated. The expected sensitivity and specificity are > 95%.

    Time frame: 24 MONTHS

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Cardiac MRI for the Detection of Cellular Rejection in Patients With Heart Transplantation

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jun 3, 2010
Registry last updated
Sep 1, 2015

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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