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

NCT ID: NCT02278497

Last Updated: 2015-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR

Group Type OTHER

ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR

Intervention Type OTHER

Interventions

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ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spectrum Dynamics

INDUSTRY

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medecine Nucleaire

Caen, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Denis Agostini, MD,PhD

Role: primary

Other Identifiers

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14-006

Identifier Type: -

Identifier Source: org_study_id