Heart DiseaseRECOPENCT01231815
Coronary Flow Reserve Evaluation in PET and in MRI Scanner in Heart Transplanted Patients : Comparison With Multi-detectors Scanner
A study testing 15O-H2O PET - and MRI in people with Heart Disease, run by University Hospital, Caen at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease
- What is being tested?
- 15O-H2O PET - and MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with heart transplantation > 3 years
- Candidate to a routine coronary angiography
- Age > 18 years old
- signed informed consent
Who cannot join
- 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...
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- 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,...)
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHU de Caen - GIP Cyceron
Caen, 14000
Alain MANRIQUE, MD, +33 2 31 47 02 82, manrique@cyceron.fr
Cynthia BONDIS, +33 2 31 06 57 80, bondis-c@chu-caen.fr
- Recruiting
CHU de Rouen
Rouen, 76000
Michel REDONNET, MD, +33 2 32 88 81 97, Michel.Redonnet@chu-rouen.fr
Catherine NAFEH, MD, +33 2 32 88 81 97, catherine.nafeh-bizet@chu-rouen.fr
About this study
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.
Read the 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
- Heart Disease
- Being tested
- 15O-H2O PET -, MRI
- Keywords
- Heart transplantation
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15O-H2O PET -Radiation
Assessment of coronary reserve using PET
MRIRadiation
Assessment of coronary reserve using MRI
| Study group | Role | What they receive |
|---|---|---|
| PET | Experimental | 15O-H2O PET Receives: Radiation: 15O-H2O PET - |
| MRI | Experimental | MRI Receives: Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the coronary flow reserve by a quantitative method (PET ...
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Manrique, MD, Principal investigator, GIP Cyceron - CHU de Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231815
- Sponsor's protocol ID
- 2008-007746-58
- Other IDs
- 2008
- Acronym
- RECOPE
- Status last verified
- Apr 2014
- First submitted
- 29 Oct 2010
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Flow Reserve Evaluation in PET and in MRI Scanner in Heart Transplanted Patients : Comparison With Multi-detectors Scanner
- ClinicalTrials.gov ID
- NCT01231815
- Acronym / sponsor ID
- RECOPE / 2008-007746-58
- Conditions
- Heart Disease
- Keywords
- Heart transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 1 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PET | Experimental | Radiation: 15O-H2O PET -15O-H2O PET |
| MRI | Experimental | Radiation: MRIMRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with heart transplantation > 3 years
- Candidate to a routine coronary angiography
- Age > 18 years old
- signed informed consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15O-H2O PET -Assessment of coronary reserve using PET | Radiation | PET |
| MRIAssessment of coronary reserve using MRI | Radiation | MRI |
Primary outcome
To compare the coronary flow reserve by a quantitative method (PET ...
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Manrique, MD principal investigator
GIP Cyceron - CHU de Caen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15O-H2O PET - and MRI in people with Heart Disease, run by University Hospital, Caen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain MANRIQUE, MD (+33 2 31 47 02 87, manrique@cyceron.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the coronary flow reserve by a quantitative method (PET ... (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.