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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Disease
• Intervention / Treatment: Radiation: 15O-H2O PET -; Radiation: MRI

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • CHU de Caen - GIP Cyceron
    • Contact: Alain MANRIQUE, MD; Phone Number: +33 2 31 47 02 82; Email: manrique@cyceron.fr
    • Contact: Cynthia BONDIS; Phone Number: +33 2 31 06 57 80; Email: bondis-c@chu-caen.fr
    • Sub-Investigator: Annette BELIN, MD
    • Sub-Investigator: Michèle HAMON, PhD
  • Rouen, France, 76000
    • Recruiting
    • CHU de Rouen
    • Contact: Michel REDONNET, MD; Phone Number: +33 2 32 88 81 97; Email: Michel.Redonnet@chu-rouen.fr
    • Contact: Catherine NAFEH, MD; Phone Number: +33 2 32 88 81 97; Email: catherine.nafeh-bizet@chu-rouen.fr
    • Sub-Investigator: Jean-Nicolas DACHER, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,...)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET; 15O-H2O PET	Radiation: 15O-H2O PET -; Assessment of coronary reserve using PET
Experimental: MRI	Radiation: MRI; Assessment of coronary reserve using MRI

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Alain Manrique, MD, GIP Cyceron - CHU de Caen

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: October 29, 2010
• First Submitted That Met QC Criteria: October 29, 2010
• First Posted (Estimate): November 1, 2010

Study Record Updates

• Last Update Posted (Estimate): April 9, 2014
• Last Update Submitted That Met QC Criteria: April 8, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Heart transplantation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 2008-007746-58