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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Sudden Death
• Intervention / Treatment: Radiation: MIBG for diagnostic purpose

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.

• Study Type: Interventional
• Enrollment (Anticipated): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ICD implantation; MIBG for diagnostic purpose: MIBG scintigraphy for diagnostic purpose	Radiation: MIBG for diagnostic purpose; All patients will undergo the diagnostic test specific to the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sudden cardiac death		1-3 months
Overall mortality		1-3 months
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	every 6 months during 3 years
sudden cardiac death		every 6 months during 3 years
Overall mortality		every 6 months during 2 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2010
• Primary Completion (ACTUAL): March 1, 2017
• Study Completion (ANTICIPATED): January 1, 2018

Study Registration Dates

• First Submitted: July 9, 2010
• First Submitted That Met QC Criteria: August 19, 2010
• First Posted (ESTIMATE): August 20, 2010

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Heart failure; Implantable Cardioverter Defibrillator; Sudden death; MIBG scintigraphy
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death; Heart Failure; Death, Sudden
• Other Study ID Numbers: AOM : 08085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED