Back to resultsAssessment of Coronary Flow Reserve by PET-H215O and FFR. Comparison With Dynamic Acquisition Using CZT Camera (WATERDAY)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Medecine NucleaireRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR
Arm Description
Outcomes
Primary Outcome Measures
Assess myocardial coronary reserve by cardiac CZT camera and Tcmibi comparing with the PET and the water marked during coronary FFR (Flow Fraction Reserve)
Secondary Outcome Measures
Full Information
NCT ID
NCT02278497
First Posted
October 28, 2014
Last Updated
July 30, 2015
Sponsor
University Hospital, Caen
Collaborators
Spectrum Dynamics
1. Study Identification
Unique Protocol Identification Number
NCT02278497
Brief Title
Assessment of Coronary Flow Reserve by PET-H215O and FFR. Comparison With Dynamic Acquisition Using CZT Camera
Acronym
WATERDAY
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
Spectrum Dynamics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Medecine Nucleaire
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis Agostini, MD,PhD
Phone
0231063246
First Name & Middle Initial & Last Name & Degree
Alain MANRIQUE, Md,PhD
12. IPD Sharing Statement
Learn more about this trial
Assessment of Coronary Flow Reserve by PET-H215O and FFR. Comparison With Dynamic Acquisition Using CZT Camera
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