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

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Other: ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR

• Registration Number: NCT02278497
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-10-30
• Study Start: 2014-11
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-30
• Last Update Posted: 2015-07-31
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR	ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR	-

Primary Outcome Measures

Name	Time	Method
Assess myocardial coronary reserve by cardiac CZT camera and Tcmibi comparing with the PET and the water marked during coronary FFR (Flow Fraction Reserve)	baseline

Trial Locations

Locations (1)

Medecine Nucleaire; 🇫🇷 Caen, France