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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01136135
First received: February 26, 2010
Last updated: December 10, 2013
Last verified: June 2011
  Purpose

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.


Condition Intervention
Heart Transplant Rejection
Other: CARDIAC MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac MRI for the Detection of Cellular Rejection in Patients With Heart Transplantation

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: February 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CARDIAC MRI Other: CARDIAC MRI
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.
Other Name: CARDIAC MRI

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who had undergone cardiac transplants

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136135

Locations
France
Hopital Necker
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Ou Phalla, MCU PH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01136135     History of Changes
Other Study ID Numbers: P081113, 2009-A00985-52
Study First Received: February 26, 2010
Last Updated: December 10, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Heart transplant rejection
cardiac MRI
diagnosis

ClinicalTrials.gov processed this record on October 23, 2014