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?

NCT01258283 | Terminated

• 2 other identifiers: PHRC-I/2008/VB-032008-007163-16
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Defibrillators, Implantable

Outcome Measures

Primary Outcomes (1)

• Presence/absence of a triggering of the defibrillator within 3 years of follow up

  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

Study Arms (1)

The study population

See inclusion and exclusion criteria.

Other: Addional imaging

Interventions

Addional imaging 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

The study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Location

Study Officials

• Vincent Boudousq, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: June 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: June 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2015-10

Locations

FR (2)