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 is currently recruiting participants.
Verified March 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01258283
First received: December 9, 2010
Last updated: March 26, 2013
Last verified: March 2013
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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.
| Estimated Enrollment: | 96 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | January 2017 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258283
Contacts
| Contact: Vincent M Boudousq, MD | +33.4.66.68.42.25 | vincent.boudousq@chu-nimes.fr |
| Contact: Carey M Suehs | 3466686788 | carey.suehs@chu-nimes.fr |
Locations
| France | |
| Centre Hospitalier Universitaire de Nîmes | Recruiting |
| Nîmes, Gard, France, 30029 | |
| Sub-Investigator: Madeleine Rubini, MD | |
| Sub-Investigator: Lionel Beck, MD | |
| Sub-Investigator: Patrick Messner, MD | |
| Principal Investigator: Vincent Boudousq, MD | |
| Sub-Investigator: Stephane Renaud, MD | |
| Sub-Investigator: Laurent Collombier, MD | |
| Sub-Investigator: Pierre Olivier Kotzki, MD PhD | |
| Centre Hospitalier Universitaire de Montpellier | Not yet recruiting |
| Montpellier, France | |
| Sub-Investigator: D Mariano Goulart, MD | |
| Sub-Investigator: C Piot, MD | |
| Sub-Investigator: F Raczka, MD | |
| Sub-Investigator: JL Pasquie, MD | |
| Sub-Investigator: JM Davy, MD | |
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: | March 26, 2013 |
| 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 Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013