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Assessment of Coronary Flow Reserve by PET-H215O and FFR. Comparison With Dynamic Acquisition Using CZT Camera (WATERDAY)

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ClinicalTrials.gov Identifier: NCT02278497
Recruitment Status : Unknown
Verified July 2015 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : October 30, 2014
Last Update Posted : July 31, 2015
Sponsor:
Collaborator:
Spectrum Dynamics
Information provided by (Responsible Party):
University Hospital, Caen

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : November 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR Other: ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278497


Locations
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France
Medecine Nucleaire Recruiting
Caen, France, 14000
Contact: Denis Agostini, MD,PhD    0231063246      
Sub-Investigator: Alain MANRIQUE, Md,PhD         
Sponsors and Collaborators
University Hospital, Caen
Spectrum Dynamics

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02278497    
Other Study ID Numbers: 14-006
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases