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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Caen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01231815
First received: October 29, 2010
Last updated: April 8, 2014
Last verified: April 2014

October 29, 2010
April 8, 2014
November 2010
December 2014   (final data collection date for primary outcome measure)
To compare the coronary flow reserve by a quantitative method (PET ... [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01231815 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Coronary Flow Reserve Evaluation in PET and in MRI Scanner in Heart Transplanted Patients : Comparison With Multi-detectors Scanner
Coronary Flow Reserve Evaluation in PET and in MRI Scanner in Heart Transplanted Patients : Comparison With Multi-detectors Scanner

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.

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).
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Heart Disease
  • Radiation: 15O-H2O PET -
    Assessment of coronary reserve using PET
  • Radiation: MRI
    Assessment of coronary reserve using MRI
  • Experimental: PET
    15O-H2O PET
    Intervention: Radiation: 15O-H2O PET -
  • Experimental: MRI
    MRI
    Intervention: Radiation: MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2014
December 2014   (final data collection date for primary outcome measure)

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,...)
Both
18 Years and older
No
Contact: Alain MANRIQUE, MD +33 2 31 47 02 87 manrique@cyceron.fr
Contact: Denis AGOSTINI, PhD +33 2 31 06 32 46 agostini-d@chu-caen.fr
France
 
NCT01231815
2008-007746-58
No
University Hospital, Caen
University Hospital, Caen
Not Provided
Principal Investigator: Alain Manrique, MD GIP Cyceron - CHU de Caen
University Hospital, Caen
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP