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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 123I-mIBG (meta-iodobenzylquanidine | 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. | 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 Lombard | 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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Of 587 participants, 6 were withdrawn prior to receiving investigational medicinal product (IMP). A total of 581 participants (533 Heart Failure [HF] and 48 control), were dosed at the 54 centers. However, one of these participants was administered 123I-mIBG not manufactured by the sponsor, and therefore excluded from all analyses.
A total of 712 participants were screened, of whom 587 participants were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | AdreView--Heart Failure Group | 123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose. |
| FG001 | AdreView--Control Group | 123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received IMP manufactured by the sponsor.
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| ID | Title | Description |
|---|---|---|
| BG000 | AdreView--Heart Failure Group | 123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose, to participants who were at a high risk of heart failure. |
| BG001 | AdreView--Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Primary efficacy population was 520 participants in HF group who received IMP and had a diagnostic (optimal or sub-optimal) 3 hour 50 minute planar image. Images from 2 HF participants were inadvertently not submitted and not presented to blinded readers. Here, N=efficacy population and n=number of participants assessed by specific readers. | Posted | Number | number of adverse cardiac events | Approximately 24 months from the date of administration of 123I-mIBG |
|
Up to 30 hours after administration of the IMP
A total of 7 participants were withdrawn from the study, of which 6 were withdrawn prior to receiving IMP and 1 patient received 123I-mIBG of another manufacturer. Therefore, this latter participant was withdrawn from all analyses.
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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 Group | 123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose M Zubeldia, M.D. | GE Healthcare | 011-44-1494-543137 | jose.zubeldia@ge.com |
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| 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 |
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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. |
| Protocol Violation |
|
| Adverse Event |
|
| Failed Inclusion Exclusion Criteria |
|
| Other |
|
123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose, to participants who were at no risk of heart failure.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | AdreView-Heart Failure Group With High H/M Ratio | Participants in HF group who had high H/M ratio (more than or equal to 1.6) |
| OG001 | AdreView-Heart Failure Group With Low H/M Ratio | Participants in HF group who had low H/M ratio (less than 1.6) |
|
|
|
| 1 |
| 532 |
| 0 |
| 532 |
| EG001 | AdreView --Control Group | 123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose. | 0 | 48 | 0 | 48 |
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.
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D006847 | Hydrocarbons, Iodinated |
| D006846 | Hydrocarbons, Halogenated |