Coronary Flow Reserve Evaluation in PET and in MRI Scanner in Heart Transplanted Patients : Comparison With Multi-detectors Scanner
RECOPE
1 other identifier
interventional
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2010
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2010
CompletedFirst Posted
Study publicly available on registry
November 1, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 9, 2014
April 1, 2014
4.1 years
October 29, 2010
April 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the coronary flow reserve by a quantitative method (PET ...
6 months
Study Arms (2)
PET
EXPERIMENTAL15O-H2O PET
MRI
EXPERIMENTALMRI
Interventions
Eligibility Criteria
You may qualify if:
- Patient with heart transplantation \> 3 years
- Candidate to a routine coronary angiography
- Age \> 18 years old
- signed informed consent
You may not qualify if:
- 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,...)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU de Caen - GIP Cyceron
Caen, 14000, France
CHU de Rouen
Rouen, 76000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alain Manrique, MD
GIP Cyceron - CHU de Caen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2010
First Posted
November 1, 2010
Study Start
November 1, 2010
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
April 9, 2014
Record last verified: 2014-04