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

Can we Better Select Patients With Heart Failure for a Primary Prevention Indication of Implantable Cardioverter Defibrillator (ICD)? Evaluation of the Diagnostic Value of 123I Meta-iodobenzylguanidine (MIBG)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01185756
Acronym
MISTIC
Enrollment
330
Registered
2010-08-20
Start date
2010-09-30
Completion date
2018-01-31
Last updated
2018-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Sudden Death

Keywords

Heart failure, Sudden death, Implantable Cardioverter Defibrillator, MIBG scintigraphy

Brief 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.

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.

Interventions

RADIATIONMIBG for diagnostic purpose

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of the cardiac MIBG uptake ratio for identification of patients at very low risk of severe ventricular arrhythmias.1-3 monthsDescription appropriate therapy delivered by the ICD, or sustained ventricular tachycardia.

Secondary

MeasureTime frameDescription
Sudden cardiac death1-3 months
Overall mortality1-3 months
Assessment of the cardiac MIBG uptake ratio for identification of patients at very low risk of severe ventricular arrhythmias.every 6 months during 3 yearsdescription appropriate therapy delivered by the ICD or sustained ventricular tachycardia
sudden cardiac deathevery 6 months during 3 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026