Trials / Unknown
UnknownNCT01231815
Coronary Flow Reserve Evaluation in PET and in MRI Scanner in Heart Transplanted Patients : Comparison With Multi-detectors Scanner
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- University Hospital, Caen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | 15O-H2O PET - | Assessment of coronary reserve using PET |
| RADIATION | MRI | Assessment of coronary reserve using MRI |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2010-11-01
- Last updated
- 2014-04-09
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT01231815. Inclusion in this directory is not an endorsement.