Defibrillators, ImplantableNCT01258283
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?
An observational study of Defibrillators, Implantable, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Defibrillators, Implantable
- What is being tested?
- Addional imaging
- How many people
- 6 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2011to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Universitaire de Montpellier
Montpellier
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, 30029
About this study
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?
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
- Being tested
- Addional imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addional imagingOther
All patients will systematically have an 18F-FDG PET-CT (18F-fluorodeoxyglucose positron emission tomography/computed tomography) and a 123MIBG (Iodine 123 metaiodobenzylguanidine) scintigraphy
| Study group | Role | What they receive |
|---|---|---|
| The study population | See inclusion and exclusion criteria. Receives: Other: Addional imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startJun 2011
- Primary completionAug 2015
- Study completionJun 2016
Why it stopped: Inclusion rate too slow / infeasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Defibrillators, ImplantableStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Boudousq, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258283
- Sponsor's protocol ID
- PHRC-I/2008/VB-03
- Other IDs
- 2008-007163-16, 2008
- Status last verified
- Oct 2015
- First submitted
- 9 Dec 2010
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT01258283
- Acronym / sponsor ID
- PHRC-I/2008/VB-03
- Conditions
- Defibrillators, Implantable
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inclusion rate too slow / infeasible.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Other: Addional imagingSee inclusion and exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Addional imagingAll patients will systematically have an 18F-FDG PET-CT (18F-fluorodeoxyglucose positron emission tomography/computed tomography) and a 123MIBG (Iodine 123 metaiodobenzylguanidine) scintigraphy | Other | The study population |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Inclusion rate too slow / infeasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Boudousq, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Defibrillators, Implantable, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inclusion rate too slow / infeasible.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence/absence of a triggering of the defibrillator within 3 years of follow up (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017; AzTrials last refreshed its copy on 3 Nov 2026.