Cardiac Amyloidosis
Conditions
Keywords
F-18 florbetapir, Amyvid, PET scan, Early detection
Brief summary
The investigators postulate that F-18 florbetapir will show improved detection of cardiac amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.
Detailed description
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.
Interventions
DRUGF-18 florbetapir
Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid).
Sponsors
Avid Radiopharmaceuticals
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with extra-cardiac biopsy-proven AL or ATTR amyloidosis 2. Patients with a ratio of affected to unaffected free light chains \>5 or free light chain difference of \>50
Exclusion criteria
1. Echocardiographic evidence of cardiac amyloidosis with septal and posterior wall thickness ≥ 13mm 2. Contraindication to florbetapir or its components 3. Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Myocardial F18-florbetapir Uptake | at the time of the PET scan | Number of participants with quantitative F18-florbetapir uptake above previously defined control values |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| At Risk for Symptomatic AL Cardiac Amyloidosis Patients with MGUS at risk for developing AL amyloidosis | 2 |
| At Risk for Symptomatic ATTR Cardiac Amyloidosis Patients with biopsy proven extra-cardiac ATTR amyloidosis | 6 |
| Control Patients Negative carpal tunnel biopsy | 4 |
| Total | 12 |
Baseline characteristics
| Characteristic | At Risk for Symptomatic AL Cardiac Amyloidosis | At Risk for Symptomatic ATTR Cardiac Amyloidosis | Control Patients | Total |
|---|---|---|---|---|
| Age, Continuous | 73.5 years STANDARD_DEVIATION 3.5 | 71.4 years STANDARD_DEVIATION 5.2 | 72 years STANDARD_DEVIATION 6.9 | 72 years STANDARD_DEVIATION 5.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 5 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 6 | 0 / 4 |
| other Total, other adverse events | 0 / 2 | 0 / 6 | 0 / 4 |
| serious Total, serious adverse events | 0 / 2 | 0 / 6 | 0 / 4 |
Outcome results
Primary
Quantitative Myocardial F18-florbetapir Uptake
Number of participants with quantitative F18-florbetapir uptake above previously defined control values
Time frame: at the time of the PET scan
Population: All participants had quantitative uptake of F18-Flobetapir
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| At Risk for Symptomatic AL Cardiac Amyloidosis | Quantitative Myocardial F18-florbetapir Uptake | 2 Participants |
| At Risk for Symptomatic ATTR Cardiac Amyloidosis | Quantitative Myocardial F18-florbetapir Uptake | 6 Participants |
| Control Patients | Quantitative Myocardial F18-florbetapir Uptake | 4 Participants |