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

Primary Purpose

Heart Failure, Sudden Death

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MIBG for diagnostic purpose
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Heart failure, Sudden death, Implantable Cardioverter Defibrillator, MIBG scintigraphy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Groupe Hospitalier Bichat - Claude Bernard

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICD implantation

Arm Description

MIBG for diagnostic purpose: MIBG scintigraphy for diagnostic purpose

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sudden cardiac death
Overall mortality
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
sudden cardiac death
Overall mortality

Full Information

First Posted
July 9, 2010
Last Updated
January 10, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01185756
Brief Title
MIBG Scintigraphy as a Tool for Selecting Patients Requiring Implantable Cardioverter Defibrillator (ICD)
Acronym
MISTIC
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Sudden Death
Keywords
Heart failure, Sudden death, Implantable Cardioverter Defibrillator, MIBG scintigraphy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICD implantation
Arm Type
Experimental
Arm Description
MIBG for diagnostic purpose: MIBG scintigraphy for diagnostic purpose
Intervention Type
Radiation
Intervention Name(s)
MIBG for diagnostic purpose
Intervention Description
All patients will undergo the diagnostic test specific to the study.
Primary Outcome Measure Information:
Title
Assessment of the cardiac MIBG uptake ratio for identification of patients at very low risk of severe ventricular arrhythmias.
Description
Description appropriate therapy delivered by the ICD, or sustained ventricular tachycardia.
Time Frame
1-3 months
Secondary Outcome Measure Information:
Title
Sudden cardiac death
Time Frame
1-3 months
Title
Overall mortality
Time Frame
1-3 months
Title
Assessment of the cardiac MIBG uptake ratio for identification of patients at very low risk of severe ventricular arrhythmias.
Description
description appropriate therapy delivered by the ICD or sustained ventricular tachycardia
Time Frame
every 6 months during 3 years
Title
sudden cardiac death
Time Frame
every 6 months during 3 years
Title
Overall mortality
Time Frame
every 6 months during 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Le Guludec, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Bichat - Claude Bernard
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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