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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01258283
Other study ID # PHRC-I/2008/VB-03
Secondary ID 2008-007163-16
Status Terminated
Phase N/A
First received December 9, 2010
Last updated February 2, 2017
Start date June 2011
Est. completion date June 2016

Study information

Verified date October 2015
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date June 2016
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Centre Hospitalier Universitaire de Montpellier Montpellier
France Centre Hospitalier Universitaire de Nîmes Nîmes Gard

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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