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

July 30, 2015 updated by: University Hospital, Caen

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • Recruiting
        • Médecine Nucléaire
        • Contact:
          • Denis Agostini, MD,PhD
          • Phone Number: 0231063246
        • Sub-Investigator:
          • Alain MANRIQUE, Md,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

Spectrum Dynamics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

October 30, 2014

Study Record Updates

Last Update Posted (Estimate)

July 31, 2015

Last Update Submitted That Met QC Criteria

July 30, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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