PET / CT With 18F-FDG: Does it Optimize the I 123-MIBG Imaging Results in the Search for Discriminating Factors for the Implementation of an Implantable Defibrillator?

February 2, 2017 updated by: Centre Hospitalier Universitaire de Nīmes

PET / CT With 18F-FDG (18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography): Does it Optimize the I 123-MIBG (Iodine 123 Metaiodobenzylguanidine) Imaging Results in the Search for Discriminating Factors for the Implementation of an Implantable Defibrillator for Primary Prevention in Patients With Heart Failure of Ischemic Origin?

The main objective of this study is to determine among the patients included a subpopulation that does not need a defibrillator.

This will be done by comparing the number of discordant segments (mismatch) between patients who have a severe arrhythmia (ventricular tachycardia or ventricular fibrillation) with appropriate electrical therapy within 3 years of monitoring and others. "Mismatch" in the definition of this objective is the usual definition: score 3.4 in I123-MIBG (Iodine 123 metaiodobenzylguanidine) and PET at 0,1,2.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6

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
      • Montpellier, France
        • Centre Hospitalier Universitaire de Montpellier
    • Gard
      • Nîmes, Gard, France, 30029
        • Centre Hospitalier Universitaire de Nîmes

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Coronary patients that should benefit from ICD (Implanted Cardiac Defibrillator) implantation for primary prevention according to current recommendations, that is to say with LVEF (left ventricular ejection fraction) <30% in NYHA (New York Heart Association) stage II or III and within one month of an myocardial infarction or within 3 months of a complete revascularization.

Description

Inclusion Criteria:

  • Patient with ischemic heart disease with heart failure
  • Patients who received myocardial perfusion scintigraphy
  • Indication for the implantation of an ICD installed according to current recommendations : LVEF <30% and NYHA (New York Heart Association) stage II, III.
  • The subject must have given his informed consent and signed consent
  • The subject must be a member or beneficiary of a social security system

Exclusion Criteria:

  • Pregnant or lactating women
  • History of "open heart" cardiovascular surgery
  • Inability to sign informed consent (patient under guardianship)
  • Patients with diabetes mellitus
  • Patient with proven dementia
  • Person refusing to sign the consent
  • Someone who already has an ICD at baseline
  • Life expectancy less than one year (NYHA IV, other diseases such as neoplastic disease in an advanced stage)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The study population
See inclusion and exclusion criteria.
Other: Addional imaging
All patients will systematically have an 18F-FDG PET-CT (18F-fluorodeoxyglucose positron emission tomography/computed tomography) and a 123MIBG (Iodine 123 metaiodobenzylguanidine) scintigraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence/absence of a triggering of the defibrillator within 3 years of follow up
Time Frame: 3 years
The primary endpoint is the triggering of the defibrillator within 3 years of follow up. Mismatch segments will be studied as predictors of arrhythmia.
3 years

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Vincent Boudousq, MD, Centre Hospitalier Universitaire de Nîmes

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

June 1, 2011

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

December 9, 2010

First Submitted That Met QC Criteria

December 9, 2010

First Posted (Estimate)

December 10, 2010

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • PHRC-I/2008/VB-03
  • 2008-007163-16 (Other Identifier: RCB number)

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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