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Low enrollment
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| Name | Class |
|---|---|
| Avid Radiopharmaceuticals | INDUSTRY |
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The investigators postulate that F-18 florbetapir will show improved detection of cardiac amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.
F-18 florbetapir is currently used for the early detection of brain amyloid (Alzheimer's disease). The hypothesis is that F-18 florbetapir will detect amyloid deposition in myocardium prior to current non-invasive diagnostic measures, particular electrocardiography with strain and technetium pyrophosphate scintigraphy. The investigators intend to use F-18 florbetapir and assess its correlation between standard non-invasive diagnostic modalities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL or TTR type amyloidosis | Experimental | The participants will undergo F-18 florbetapir PET scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-18 florbetapir | Drug | Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Myocardial F18-florbetapir Uptake | Number of participants with quantitative F18-florbetapir uptake above previously defined control values | at the time of the PET scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Nissen, MD | The Cleveland Clinic | Study Chair |
| Wael Jaber, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation (Main Campus) | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | At Risk for Symptomatic AL Cardiac Amyloidosis | Patients with MGUS at risk for developing AL amyloidosis |
| FG001 | At Risk for Symptomatic ATTR Cardiac Amyloidosis | Patients with biopsy proven extra-cardiac ATTR amyloidosis |
| FG002 | Control Patients | Negative carpal tunnel biopsy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | At Risk for Symptomatic AL Cardiac Amyloidosis | Patients with MGUS at risk for developing AL amyloidosis |
| BG001 | At Risk for Symptomatic ATTR Cardiac Amyloidosis | Patients with biopsy proven extra-cardiac ATTR amyloidosis |
| 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 | Quantitative Myocardial F18-florbetapir Uptake | Number of participants with quantitative F18-florbetapir uptake above previously defined control values | All participants had quantitative uptake of F18-Flobetapir | Posted | Count of Participants | Participants | at the time of the PET scan |
|
24 hours
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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 | At Risk for Symptomatic AL Cardiac Amyloidosis | Patients with MGUS at risk for developing AL amyloidosis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wael A. Jaber | Cleveland Clinic Foundation | 216.444.8305 | jaberw@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2016 | Feb 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D028227 | Amyloid Neuropathies, Familial |
| ID | Term |
|---|---|
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D017772 | Amyloid Neuropathies |
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| ID | Term |
|---|---|
| C545186 | florbetapir |
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| BG002 | Control Patients | Negative carpal tunnel biopsy |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Control Patients |
Negative carpal tunnel biopsy |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | At Risk for Symptomatic ATTR Cardiac Amyloidosis | Patients with biopsy proven extra-cardiac ATTR amyloidosis | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Control Patients | Negative carpal tunnel biopsy | 0 | 4 | 0 | 4 | 0 | 4 |
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| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028226 | Amyloidosis, Familial |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |