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The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcome in subjects with heart failure and in comparison to subjects without cardiovascular disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 123I-mIBG (meta-iodobenzylguanidine) | Experimental | Single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 123I-mIBG (meta-iodobenzylguanidine) | Drug | Single Dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relationship Between the Occurrence of Adverse Cardiac Event and 123I-mIBG Uptake on Planar Scintigraphy Categorized as High or Low Heart to Mediastinum (H/M) Ratio | H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Assessments were done by 3 independent readers. H/M ratios were categorized as 'Low' and 'High' based on being <1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data collected relative to time to adverse cardiac events. Data analysis to assess the relative hazard of an adverse cardiac event was performed only on HF participants categorized into 2 groups with H/M <1.6 and H/M ≥1.6 using a Cox proportional hazards model. | Approximately 24 months from the date of administration of 123I-mIBG |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Strohmeyer | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26666380 | Derived | 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. | |
| 21193691 |
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A total 515 participants (453 Heart failure [HF] and 62 control) were enrolled in the study and received a single dose of investigational medicinal product (IMP) at 43 investigational centers.
A total of 753 participants were screened, of whom 197 were screen failures due to inclusion/exclusion criteria; 24 withdrawn at participant's request; 2 withdrawn at investigator's request and 15 failed to complete all screening procedures.
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| ID | Title | Description |
|---|---|---|
| FG000 | AdreView - Heart Failure Group | AdreView (123I-mIBG [meta-iodobenzylguanidine]): 10 milliCurie (mCi) as a single intravenous dose. |
| FG001 | Adreview - Control Group | AdreView (123I-mIBG): 10 mCi as a single intravenous dose. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Derived |
| 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. |
| 20188504 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
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All participants who received IMP manufactured by the sponsor.
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| ID | Title | Description |
|---|---|---|
| BG000 | AdreView - Heart Failure | AdreView (123I-mIBG): 10 mCi as a single intravenous dose. |
| BG001 | Adreview - Control Group | AdreView (123I-mIBG): 10 mCi as a single intravenous dose. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Relationship Between the Occurrence of Adverse Cardiac Event and 123I-mIBG Uptake on Planar Scintigraphy Categorized as High or Low Heart to Mediastinum (H/M) Ratio | H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Assessments were done by 3 independent readers. H/M ratios were categorized as 'Low' and 'High' based on being <1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data collected relative to time to adverse cardiac events. Data analysis to assess the relative hazard of an adverse cardiac event was performed only on HF participants categorized into 2 groups with H/M <1.6 and H/M ≥1.6 using a Cox proportional hazards model. | Primary efficacy population included 444 participants in HF group who received IMP and had a diagnostic (optimal/sub-optimal) 3 hour 50 minute planar image. Primary efficacy analysis was based on comparing only "Adreview HF" participants with low vs. high H/M and, therefore, did not include "Adreview Control" group. | Posted | Number | number of adverse cardiac events | Approximately 24 months from the date of administration of 123I-mIBG |
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Up to 30 hours after administration of the IMP.
Analysis was performed on safety population that included all participants who received a dose of IMP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AdreView - Heart Failure | AdreView (123I-mIBG): 10 mCi as a single intravenous dose. | 6 | 453 | 0 | 453 | ||
| EG001 | Adreview - Control Group | AdreView (123I-mIBG): 10 mCi as a single intravenous dose. | 0 | 62 | 0 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular Block | Cardiac disorders | 11.1 | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | 11.1 | Systematic Assessment |
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| Bacteremia | Infections and infestations | 11.1 | Systematic Assessment |
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| Chest Pain | Musculoskeletal and connective tissue disorders | 11.1 | Systematic Assessment |
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| Abdominal Pain | Nervous system disorders | 11.1 | Systematic Assessment |
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| Syncope | Respiratory, thoracic and mediastinal disorders | 11.1 | Systematic Assessment |
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The only disclosure restriction on the PI and/or institution is that the Sponsor can review results communications prior to public release and can restrict communications regarding trial results for a period that is more than 30 days (publications/abstracts) but not to exceed 90 days (patent related issues) from the time submitted to the Sponsor to review. The PI may be asked to remove any Sponsor confidential information and/or delay publication to protect any proprietary information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Zubeldia, M.D. | GE Healthcare | 011-44-1494-543137 | jose.zubeldia@ge.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019797 | 3-Iodobenzylguanidine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D007462 | Iodobenzenes |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D006847 | Hydrocarbons, Iodinated |
| D006846 | Hydrocarbons, Halogenated |
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| Male |
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| Reader C (n=86, 352) |
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| Analysis based on Reader B readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time "t" was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively. | Cox Proportional Hazards Model | 0.001 | At 0.025 level of significance. | Hazard Ratio (HR) | 0.36 | 2-Sided | 95 | 0.18 | 0.72 | Superiority or Other |
| Analysis based on Reader C readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time "t" was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively. | Cox Proportional Hazards Model | 0.001 | At 0.025 level of significance. | Hazard Ratio (HR) | 0.35 | 2-Sided | 95 | 0.17 | 0.72 | Superiority or Other |