Back to resultsCoronary Flow Reserve Evaluation in PET and in MRI Scanner in Heart Transplanted Patients : Comparison With Multi-detectors Scanner (RECOPE)
Primary Purpose
Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
15O-H2O PET -
MRI
Sponsored by
About this trial
This is an interventional prevention trial for Heart Disease focused on measuring Heart transplantation
Eligibility 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,...)
Sites / Locations
- CHU de Caen - GIP CyceronRecruiting
- CHU de RouenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PET
MRI
Arm Description
15O-H2O PET
MRI
Outcomes
Primary Outcome Measures
To compare the coronary flow reserve by a quantitative method (PET ...
Secondary Outcome Measures
Full Information
NCT ID
NCT01231815
First Posted
October 29, 2010
Last Updated
April 8, 2014
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT01231815
Brief Title
Coronary Flow Reserve Evaluation in PET and in MRI Scanner in Heart Transplanted Patients : Comparison With Multi-detectors Scanner
Acronym
RECOPE
Official Title
Coronary Flow Reserve Evaluation in PET and in MRI Scanner in Heart Transplanted Patients : Comparison With Multi-detectors Scanner
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease
Keywords
Heart transplantation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PET
Arm Type
Experimental
Arm Description
15O-H2O PET
Arm Title
MRI
Arm Type
Experimental
Arm Description
MRI
Intervention Type
Radiation
Intervention Name(s)
15O-H2O PET -
Intervention Description
Assessment of coronary reserve using PET
Intervention Type
Radiation
Intervention Name(s)
MRI
Intervention Description
Assessment of coronary reserve using MRI
Primary Outcome Measure Information:
Title
To compare the coronary flow reserve by a quantitative method (PET ...
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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,...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain MANRIQUE, MD
Phone
+33 2 31 47 02 87
Email
manrique@cyceron.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Denis AGOSTINI, PhD
Phone
+33 2 31 06 32 46
Email
agostini-d@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Manrique, MD
Organizational Affiliation
GIP Cyceron - CHU de Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Caen - GIP Cyceron
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain MANRIQUE, MD
Phone
+33 2 31 47 02 82
Email
manrique@cyceron.fr
First Name & Middle Initial & Last Name & Degree
Cynthia BONDIS
Phone
+33 2 31 06 57 80
Email
bondis-c@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Rémi SABATIER, MD
First Name & Middle Initial & Last Name & Degree
Annette BELIN, MD
First Name & Middle Initial & Last Name & Degree
Michèle HAMON, PhD
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel REDONNET, MD
Phone
+33 2 32 88 81 97
Email
Michel.Redonnet@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Catherine NAFEH, MD
Phone
+33 2 32 88 81 97
Email
catherine.nafeh-bizet@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Jean-Nicolas DACHER, PhD
12. IPD Sharing Statement
Learn more about this trial
Coronary Flow Reserve Evaluation in PET and in MRI Scanner in Heart Transplanted Patients : Comparison With Multi-detectors Scanner
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