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

Heart Disease Clinical Trial

— RECOPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01231815
• Other study ID #: 2008-007746-58
• Status: Recruiting
• Phase: N/A
• First received: October 29, 2010
• Last updated: April 8, 2014
• Start date: November 2010
• Est. completion date: December 2014

Study information

• Verified date: April 2014
• Source: University Hospital, Caen
• Contact: Alain MANRIQUE, MD
• Phone: +33 2 31 47 02 87
• Email: manrique[@]cyceron.fr
• Is FDA regulated: No
• Health authority: French Authority : ANSM
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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,...)

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

Intervention

Radiation:
• 15O-H2O PET -
Assessment of coronary reserve using PET
• MRI
Assessment of coronary reserve using MRI

Locations

Country	Name	City	State
France	CHU de Caen - GIP Cyceron	Caen
France	CHU de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the coronary flow reserve by a quantitative method (PET ...		6 months	No