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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?

This study has been terminated.
(Inclusion rate too slow / infeasible.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01258283
First Posted: December 10, 2010
Last Update Posted: February 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
  Purpose

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.


Condition Intervention
Defibrillators, Implantable Other: Addional imaging

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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?

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 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.


Enrollment: 6
Study Start Date: June 2011
Study Completion Date: June 2016
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258283


Locations
France
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, France, 30029
Centre Hospitalier Universitaire de Montpellier
Montpellier, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Vincent Boudousq, MD Centre Hospitalier Universitaire de Nîmes
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01258283     History of Changes
Other Study ID Numbers: PHRC-I/2008/VB-03
2008-007163-16 ( Other Identifier: RCB number )
First Submitted: December 9, 2010
First Posted: December 10, 2010
Last Update Posted: February 3, 2017
Last Verified: October 2015

Additional relevant MeSH terms:
Fluorodeoxyglucose F18
3-Iodobenzylguanidine
Deoxyglucose
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents
Enzyme Inhibitors