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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.
Verified April 2013 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 11, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Heart Disease
 Radiation: 15O-H2O PET -
Radiation: MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • To compare the coronary flow reserve by a quantitative method (PET ... [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET
15O-H2O PET
 Radiation: 15O-H2O PET -
Assessment of coronary reserve using PET
Experimental: MRI
MRI
 Radiation: MRI
Assessment of coronary reserve using 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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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,...)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231815

Contacts
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

Locations
France
CHU de Caen - GIP Cyceron Recruiting
Caen, France, 14000
Contact: Alain MANRIQUE, MD     +33 2 31 47 02 82     manrique@cyceron.fr    
Contact: Cynthia BONDIS     +33 2 31 06 57 80     bondis-c@chu-caen.fr    
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     Michel.Redonnet@chu-rouen.fr    
Contact: Catherine NAFEH, MD     +33 2 32 88 81 97     catherine.nafeh-bizet@chu-rouen.fr    
Sub-Investigator: Jean-Nicolas DACHER, PhD            
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Alain Manrique, MD GIP Cyceron - CHU de Caen
  More Information

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01231815     History of Changes
Other Study ID Numbers: 2008-007746-58
Study First Received: October 29, 2010
Last Updated: April 11, 2013
Health Authority: French Health Authority : AFSSAPS

Keywords provided by University Hospital, Caen:
Heart transplantation

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013