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

Coronary Artery Disease Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02278497
• Other study ID #: 14-006
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2014
• Last updated: July 30, 2015
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR

Locations

Country	Name	City	State
France	Medecine Nucleaire	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Spectrum Dynamics

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No