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Meta-Iodobenzylguanidine Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease

NCT ID: NCT00126425

Last Updated: 2016-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

587 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-12-31

Brief Summary

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The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcomes in subjects with heart failure and in comparison to subjects without cardiovascular disease.

Detailed Description

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Conditions

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Heart Failure, Congestive

Keywords

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Heart Failure nuclear cardiology sympathetic innervation 123I-mIBG

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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123I-mIBG (meta-iodobenzylquanidine

Single dose

Group Type EXPERIMENTAL

123I-mIBG (meta-iodobenzylguanidine)

Intervention Type DRUG

Single dose

Interventions

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123I-mIBG (meta-iodobenzylguanidine)

Single dose

Intervention Type DRUG

Other Intervention Names

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Iobenguane mIBG meta-iodobenzylguanidine

Eligibility Criteria

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Inclusion Criteria

* Study subjects must be adults with an established diagnosis of heart failure (New York Heart Association Class II or III) and reduced left ventricular ejection fraction (LVEF) (≤ 35%) or be healthy volunteers without heart disease.

Exclusion Criteria

* Healthy volunteers are not eligible if they have a history diabetes mellitus, signs/symptoms of neurological disease (eg, Parkinson's Disease, multiple system atrophy, Parkinsonian syndromes), or other diseases known to affect the sympathetic nervous system.
* Subjects with New York Heart Association Class I or IV heart failure are not eligible.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Lombard

Role: STUDY_DIRECTOR

GE Healthcare

Locations

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GE Healthcare

Princeton, New Jersey, United States

Site Status

Countries

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United States

References

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Hachamovitch R, Nutter B, Menon V, Cerqueira MD. Predicting Risk Versus Predicting Potential Survival Benefit Using 123I-mIBG Imaging in Patients With Systolic Dysfunction Eligible for Implantable Cardiac Defibrillator Implantation: Analysis of Data From the Prospective ADMIRE-HF Study. Circ Cardiovasc Imaging. 2015 Dec;8(12):e003110. doi: 10.1161/CIRCIMAGING.114.003110.

Reference Type DERIVED
PMID: 26666380 (View on PubMed)

Gerson MC, Caldwell JH, Ananthasubramaniam K, Clements IP, Henzlova MJ, Amanullah A, Jacobson AF. Influence of diabetes mellitus on prognostic utility of imaging of myocardial sympathetic innervation in heart failure patients. Circ Cardiovasc Imaging. 2011 Mar;4(2):87-93. doi: 10.1161/CIRCIMAGING.110.954784. Epub 2010 Dec 30.

Reference Type DERIVED
PMID: 21193691 (View on PubMed)

Jacobson AF, Senior R, Cerqueira MD, Wong ND, Thomas GS, Lopez VA, Agostini D, Weiland F, Chandna H, Narula J; ADMIRE-HF Investigators. Myocardial iodine-123 meta-iodobenzylguanidine imaging and cardiac events in heart failure. Results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) study. J Am Coll Cardiol. 2010 May 18;55(20):2212-21. doi: 10.1016/j.jacc.2010.01.014. Epub 2010 Feb 25.

Reference Type DERIVED
PMID: 20188504 (View on PubMed)

Other Identifiers

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MBG311

Identifier Type: -

Identifier Source: org_study_id