Coronary Flow Reserve Evaluation in PET and in MRI Scanner in Heart Transplanted Patients : Comparison With Multi-detectors Scanner

Study Overview
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Brief Summary
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Heart transplantation is the ultimate therapeutic option in patients with end-stage heart failure. Since advances in the treatment of acute rejection has increased early transplant survival, cardiac allograft vasculopathy (CAV) is the main factor limiting long-term survival. The prevalence of angiographically proven CAV is high, documented in 40-50% of transplant recipients 5 years after transplantation. Therefore, annual coronary angiography remains widely used to monitor transplanted patients, although pathologic studies and intravascular ultrasonography have demonstrated that coronary angiography underestimates the severity of CAV. Perfusion SPECT may underestimate allograft vasculopathy in case of diffuse coronary lesions. In this setting, the assessment of coronary reserve by means of Positron Emission Tomography (PET) and perfusion cardiac magnetic resonance imaging (CMR) have not been investigated.

Detailed Description
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Aim of the study. The aim of the study is to compare the quantitative (using 15O-H2O PET) and semi-quantitative (using perfusion CMR) assessment of coronary reserve to the presence of coronary artery lesions documented by multidetector CT coronary angiography. Methods. 30 patients with heart transplantation > 3 yrs will be included in two heart transplantation centers (Caen and Rouen university hospitals) Expected results. To demonstrate that quantitative analysis of coronary reserve using 15O-H2O PET allows the assessment of cardiac allograft vasculopathy To establish the feasibility of adenosine stress CMR in this population To show a relationship between coronary lesions demonstrated using MDCT and the extent of coronary reserve impairment assessed using cardiac functional imaging (PET and CMR).

Official Title
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Coronary Flow Reserve Evaluation in PET and in MRI Scanner in Heart Transplanted Patients : Comparison With Multi-detectors Scanner

Conditions
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Heart Disease

Intervention / Treatment
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* Radiation: 15O-H2O PET -
* Radiation: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with heart transplantation > 3 years Candidate to a routine coronary angiography Age > 18 years old signed informed consent Exclusion Criteria: Pregnancy or breast feeding women Recent acute coronary syndrome (<4weeks) High Blood Pressure ((SBP >=180 mmHg or DBP >=110 mmHg) Significant ventricular or supraventricular arrythmia Atrioventricular 2nd or 3rd degree blocks, long QT syndrome Standard contraindications to MRI including pacemaker/defibrillator, metallic clips on brain aneurysms, metal fragment in the eye etc... Congestive heart failure Hemodynamic instability Intolerance or contraindication to adenosine (history of asthma or bronchoplastic disease). Severe and known pulmonary artery hypertension Severe hypotension < 90 mmHg Contraindication to contrast iodinated media (allergy, patients with chronic renal failure with creatinine clearance < 50 ml/min, multiple myeloma, hyperthyroidism,...)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET<br>15O-H2O PET | Radiation: 15O-H2O PET -<br>* Assessment of coronary reserve using PET<br>|
| Experimental: MRI<br>MRI | Radiation: MRI<br>* Assessment of coronary reserve using MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the coronary flow reserve by a quantitative method (PET ... |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart transplantation