Coronary Flow Reserve Evaluation in PET & in MRI Scanner in Heart

Status Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Heart Disease

Clinical Trial Details

NCT number	NCT01231815
Study type	Interventional
Source	University Hospital, Caen
Contact	Alain MANRIQUE, MD
Phone	+33 2 31 47 02 87
Email	manrique@cyceron.fr
Status	Recruiting
Phase	N/A
Start date	November 2010
Completion date	December 2014

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms