- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01136135
Cardiac Magnetic Resonance Imaging (CMRI) for Detection of Cardiac Transplant Rejection
Cardiac MRI for the Detection of Cellular Rejection in Patients With Heart Transplantation
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75015
- Hôpital Necker
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
24 MONTHS
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ou Phalla, MCU PH, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P081113
- 2009-A00985-52 (Registry Identifier: ID RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Transplant Rejection
-
Juan Francisco Delgado JimenezFundación Centro Nacional de Investigaciones Cardiovasculares Carlos IIIActive, not recruitingAntibody-mediated Rejection | Heart Transplant Rejection | Transplant FailureSpain
-
Western University, CanadaBayer; University of Alberta; Queen's University; Canadian Cardiovascular SocietyNot yet recruitingHeart Transplant Rejection
-
Helsinki University Central HospitalRecruitingHeart Transplant RejectionFinland
-
Natera, Inc.Active, not recruitingHeart Transplant RejectionUnited States
-
Menssana Research, Inc.National Heart, Lung, and Blood Institute (NHLBI)UnknownHeart Transplant RejectionUnited States
-
University of AlbertaNatera, Inc.; One LambdaRecruitingHeart Transplant RejectionUnited States, Canada, Spain, Australia, Austria, Czechia, Italy, Poland
-
Helsinki University Central HospitalRecruiting
-
CareDxActive, not recruiting
-
Mayo ClinicCompleted
-
Rush University Medical CenterCareDxCompletedKidney Transplant Rejection | Pancreas Transplant RejectionUnited States
Clinical Trials on CARDIAC MRI
-
University of FloridaOcala Royal DamesActive, not recruitingBreast CancerUnited States
-
University of MichiganNational Heart, Lung, and Blood Institute (NHLBI); Nationwide Children's Hospital and other collaboratorsCompletedPulmonary Hypertension | Congenital Heart Disease | Pediatric Congenital Heart DiseaseUnited States
-
Imperial College LondonNational Institute for Health Research, United Kingdom; Imperial College Healthcare...WithdrawnMyocardial Fibrosis | Heart Failure | End Stage Renal Failure on Dialysis | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe)United Kingdom
-
St. Jude Children's Research HospitalRecruitingSepsis | Acute Respiratory Distress Syndrome | Cardiovascular ShockUnited States
-
University Medical Center GoettingenNot yet recruitingTetralogy of Fallot | Congenital Heart DiseaseGermany
-
Cedars-Sinai Medical CenterRecruitingHealthyUnited States
-
Medical University of GrazEnrolling by invitationPulmonary Hypertension | Elevated Mean Pulmonary Arterial Pressure | Normal Mean Pulmonary Arterial PressureAustria
-
Cedars-Sinai Medical CenterNational Heart, Lung, and Blood Institute (NHLBI); University of Pittsburgh; University...Active, not recruitingCardiovascular DiseaseUnited States
-
University Hospital Birmingham NHS Foundation TrustUnknownTetralogy of FallotUnited Kingdom
-
University Hospital Birmingham NHS Foundation TrustUnknownCardiomyopathiesUnited Kingdom