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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01231815
Recruitment Status : Unknown
Verified April 2014 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : November 1, 2010
Last Update Posted : April 9, 2014
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Disease Radiation: 15O-H2O PET - Radiation: MRI Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Coronary Flow Reserve Evaluation in PET and in MRI Scanner in Heart Transplanted Patients : Comparison With Multi-detectors Scanner
Study Start Date : November 2010
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: PET
Radiation: 15O-H2O PET -
Assessment of coronary reserve using PET

Experimental: MRI
Radiation: MRI
Assessment of coronary reserve using MRI

Primary Outcome Measures :
  1. To compare the coronary flow reserve by a quantitative method (PET ... [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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,...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01231815

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Contact: Alain MANRIQUE, MD +33 2 31 47 02 87
Contact: Denis AGOSTINI, PhD +33 2 31 06 32 46

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CHU de Caen - GIP Cyceron Recruiting
Caen, France, 14000
Contact: Alain MANRIQUE, MD    +33 2 31 47 02 82   
Contact: Cynthia BONDIS    +33 2 31 06 57 80   
Sub-Investigator: Rémi SABATIER, MD         
Sub-Investigator: Annette BELIN, MD         
Sub-Investigator: Michèle HAMON, PhD         
CHU de Rouen Recruiting
Rouen, France, 76000
Contact: Michel REDONNET, MD    +33 2 32 88 81 97   
Contact: Catherine NAFEH, MD    +33 2 32 88 81 97   
Sub-Investigator: Jean-Nicolas DACHER, PhD         
Sponsors and Collaborators
University Hospital, Caen
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Principal Investigator: Alain Manrique, MD GIP Cyceron - CHU de Caen
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Responsible Party: University Hospital, Caen Identifier: NCT01231815    
Other Study ID Numbers: 2008-007746-58
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014
Keywords provided by University Hospital, Caen:
Heart transplantation
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases