ClinicalTrials.gg
Status unknownNCT01185756MISTICUpdated Jan 11, 2018

MIBG Scintigraphy as a Tool for Selecting Patients Requiring Implantable Cardioverter Defibrillator (ICD)

An interventional study of MIBG for diagnostic purpose in Heart Failure and Sudden Death, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-11.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
330
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

The aim of the study is to assess the cardiac innervation in patients with heart failure to better select candidates for an implantable cardioverter defibrillator. Cardiac innervation will be assessed using an imaging agent administered intravenously.

Read the detailed description

The survival benefit provided by implantable cardioverter defibrillator (ICD) for primary prevention of sudden cardiac death in heart failure compared to medical treatment alone is well established. First limited to the most severe patients, the indications have gradually been extended in accordance with the results of more recent studies. This beneficial effect in terms of public health is accompanied by an increase in health spending which threatens to grow strongly at short and medium term. However, the majority of ICDs implanted will not be solicited because of the overall low incidence of severe ventricular arrhythmias in the population meeting the implantation criteria. To optimize our resources, it is therefore important to better assess the risk of sudden death in those patients candidates for ICD implantation.

The overactivation of NEURO-humoral systems plays an important role in the progression of heart failure, and in the occurrence of ventricular arrhythmias. The iodine-123 meta-iodobenzylguanidine scintigraphy (MIBG), is a functional imaging method that can noninvasively evaluate cardiac sympathetic innervation. It has been shown that cardiac adrenergic hyperactivation estimated by MIBG scintigraphy was associated with a poor outcome, and that its value was independent and superior to other prognostic factors in heart failure. More importantly, the risk of occurrence of major cardiac events is minimal when the cardiac uptake of MIBG is high. Furthermore, plasma natriuretic peptides (particularly BNP and NT-proBNP), which are other indicators of the NEURO-hormonal activation used in the diagnosis and assessment of prognosis in heart failure, are predictive of the risk of occurrence of sudden death in the same population. In summary, the MIBG scintigraphy and NT-proBNP are two prognostic markers in heart failure related to the degree of NEURO-hormonal dysfunction, and have a good negative predictive value of mortality. Their combined use could therefore help identify patients at low risk of severe arrhythmias.These tests are not currently part of heart failure diagnosis in patients who are candidates for ICD implantation.

02

Conditions studied

  • Heart Failure
  • Sudden Death

Keywords

  • Heart failure
  • Sudden death
  • Implantable Cardioverter Defibrillator
  • MIBG scintigraphy
03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 330 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Indication for ICD in primary prevention according to European Society of Cardiology guidelines

Exclusion criteria

Exclusion Criteria:

  • Secondary prevention indication of ICD
  • Acute coronary syndrome within the last 40 days
  • Revascularization procedure (bypass or percutaneous coronary angioplasty) performed within the last 3 months of planned
  • Pregnancy or lactating female
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
330 participants (estimated)

Study arms

  • Experimental
    ICD implantation

    MIBG for diagnostic purpose: MIBG scintigraphy for diagnostic purpose

    Radiation: MIBG for diagnostic purpose

Interventions

  • RadiationMIBG for diagnostic purpose

    All patients will undergo the diagnostic test specific to the study.

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What researchers measure

Primary outcomes

  1. Assessment of the cardiac MIBG uptake ratio for identification of patients at very low risk of severe ventricular arrhythmias.

    Description appropriate therapy delivered by the ICD, or sustained ventricular tachycardia.

    Time frame: 1-3 months

Secondary outcomes

  1. Sudden cardiac death

    Time frame: 1-3 months

  2. Overall mortality

    Time frame: 1-3 months

  3. Assessment of the cardiac MIBG uptake ratio for identification of patients at very low risk of severe ventricular arrhythmias.

    description appropriate therapy delivered by the ICD or sustained ventricular tachycardia

    Time frame: every 6 months during 3 years

  4. sudden cardiac death

    Time frame: every 6 months during 3 years

  5. Overall mortality

    Time frame: every 6 months during 2 years

07

Study locations

1 site
  • Groupe Hospitalier Bichat - Claude Bernard
    Paris, Ile De France 75018, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01185756
Responsible party
Sponsor
First posted
Aug 20, 2010
Start date
Sep 2010
Primary completion
Mar 2017
Completion
Jan 2018 (estimated)
Last update
Jan 11, 2018

Study contacts

Dominique Le Guludec, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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