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?

NCT ID: NCT01258283

Last Updated: 2017-02-03

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

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Defibrillators, Implantable

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The study population

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Addional imaging

Intervention Type OTHER

All patients will systematically have an 18F-FDG PET-CT (18F-fluorodeoxyglucose positron emission tomography/computed tomography) and a 123MIBG (Iodine 123 metaiodobenzylguanidine) scintigraphy

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent Boudousq, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

Site Status

Centre Hospitalier Universitaire de Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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2008-007163-16

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC-I/2008/VB-03

Identifier Type: -

Identifier Source: org_study_id

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