Coronary Artery DiseaseWATERDAYNCT02278497
Assessment of Coronary Flow Reserve by PET-H215O and FFR. Comparison With Dynamic Acquisition Using CZT Camera
A study testing ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR in people with Coronary Artery Disease, run by University Hospital, Caen at 1 site in France.
Trial summary
The study will assess coronary flow reserve by PET-H215O and FFR in patients suspected of coroanry artery disease. This a comparative study with dynamic acquisition using CZT camera and 99mcTc-mibi. 20 patients will have those measurements. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Dec 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient between 18 and 80 years
- Suspected coronary disease and / or coronary syndrome patient ST-
- Patient who has been informed of the study and has given his informed consent
- Patient affiliated to a social security system.
Who cannot join
- Patient having no coronary disease at coronary angiography with FFR on the 3 main epicardial arteries (absence of ≥ 50% stenosis of at least one artery)
- Delay of Care grater than 30 days between the PET and SPECT imaging and the diagnostic coronary angiography
- Patient with a recent history of myocardial infarction and STEMI, unstable angina
- Patient with extra-cardiac disease whose prognosis can interfere with the treatment decision
- Pregnant or lactating women
- Patient allergic to contrast products during coronary angiography
- Patient with MDRD clearance les than 60 ml / min
- Patient Under guardianship, or unable to understand the purpose of the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Medecine Nucleaire
Caen, 14000
Denis Agostini, MD,PhD, 0231063246
Alain MANRIQUE, Md,PhD
About this study
Official title: Assessment of Coronary Flow Reserve by PET-H215O and FFR in Patients Suspected of Coroanry Artery Disease. a Comparative Study With Dynamic Acquisition Using CZT Camera and 99mcTc-mibi.
The study will assess coronary flow reserve by PET-H215O and FFR in patients suspected of coroanry artery disease. This a comparative study with dynamic acquisition using CZT camera and 99mcTc-mibi. 20 patients will have those measurements.
- Conditions
- Coronary Artery Disease
- Being tested
- ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFROther
| Study group | Role | What they receive |
|---|---|---|
| ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR | Other | Not described Receives: Other: ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess myocardial coronary reserve by cardiac CZT camera and Tcmibi comparing with the PET and the water marked during coronary FFR (Flow Fraction Reserve)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Spectrum Dynamics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278497
- Sponsor's protocol ID
- 14-006
- Acronym
- WATERDAY
- Status last verified
- Jul 2015
- First submitted
- 28 Oct 2014
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coronary Flow Reserve by PET-H215O and FFR in Patients Suspected of Coroanry Artery Disease. a Comparative Study With Dynamic Acquisition Using CZT Camera and 99mcTc-mibi.
- ClinicalTrials.gov ID
- NCT02278497
- Acronym / sponsor ID
- WATERDAY / 14-006
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Spectrum Dynamics
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Oct 2014 (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.
The study will assess coronary flow reserve by PET-H215O and FFR in patients suspected of coroanry artery disease. This a comparative study with dynamic acquisition using CZT camera and 99mcTc-mibi. 20 patients will have those measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR | Other | Other: ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient between 18 and 80 years
- Suspected coronary disease and / or coronary syndrome patient ST-
- Patient who has been informed of the study and has given his informed consent
- Patient affiliated to a social security system.
Key exclusion criteria (8 listed)
- Patient having no coronary disease at coronary angiography with FFR on the 3 main epicardial arteries (absence of ≥ 50% stenosis of at least one artery)
- Delay of Care grater than 30 days between the PET and SPECT imaging and the diagnostic coronary angiography
- Patient with a recent history of myocardial infarction and STEMI, unstable angina
- Patient with extra-cardiac disease whose prognosis can interfere with the treatment decision
- Pregnant or lactating women
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 |
|---|---|---|
| ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR | Other | ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR |
Primary outcome
Assess myocardial coronary reserve by cardiac CZT camera and Tcmibi comparing with the PET and the water marked during coronary FFR (Flow Fraction Reserve)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR in people with Coronary Artery Disease, run by University Hospital, Caen at 1 site 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 8 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 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess myocardial coronary reserve by cardiac CZT camera and Tcmibi comparing with the PET and the water marked during coronary FFR (Flow Fraction Reserve) (time frame: baseline). 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 31 Jul 2015.