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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:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01258283
First received: December 9, 2010
Last updated: October 9, 2014
Last verified: October 2014
  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 ] [ Designated as safety issue: No ]
    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
Estimated Study Completion Date: April 2016
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 9, 2010
Last Updated: October 9, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
3-Iodobenzylguanidine
Fluorodeoxyglucose F18
Antineoplastic Agents
Diagnostic Uses of Chemicals
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014