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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01185756
First received: July 9, 2010
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Heart Failure
Sudden Death
Radiation: MIBG for diagnostic purpose

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Assessment of the cardiac MIBG uptake ratio for identification of patients at very low risk of severe ventricular arrhythmias. [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]
    Description appropriate therapy delivered by the ICD, or sustained ventricular tachycardia.


Secondary Outcome Measures:
  • Sudden cardiac death [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]
  • Overall mortality [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]
  • Assessment of the cardiac MIBG uptake ratio for identification of patients at very low risk of severe ventricular arrhythmias. [ Time Frame: every 6 months during 3 years ] [ Designated as safety issue: No ]
    description appropriate therapy delivered by the ICD or sustained ventricular tachycardia

  • sudden cardiac death [ Time Frame: every 6 months during 3 years ] [ Designated as safety issue: No ]
  • Overall mortality [ Time Frame: every 6 months during 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: September 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185756

Locations
France
Groupe Hospitalier Bichat - Claude Bernard
Paris, Ile de France, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Dominique Le Guludec, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01185756     History of Changes
Other Study ID Numbers: AOM : 08085
Study First Received: July 9, 2010
Last Updated: February 17, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Heart failure
Sudden death
Implantable Cardioverter Defibrillator
MIBG scintigraphy

Additional relevant MeSH terms:
Death
Death, Sudden
Heart Failure
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
3-Iodobenzylguanidine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on August 21, 2014