Trial Outcomes & Findings for The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis (NCT NCT03040427)
NCT ID: NCT03040427
Last Updated: 2021-07-27
Results Overview
Number of participants with quantitative F18-florbetapir uptake above previously defined control values
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
at the time of the PET scan
Results posted on
2021-07-27
Participant Flow
Participant milestones
| Measure |
At Risk for Symptomatic AL Cardiac Amyloidosis
Patients with MGUS at risk for developing AL amyloidosis
|
At Risk for Symptomatic ATTR Cardiac Amyloidosis
Patients with biopsy proven extra-cardiac ATTR amyloidosis
|
Control Patients
Negative carpal tunnel biopsy
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
6
|
4
|
|
Overall Study
COMPLETED
|
2
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis
Baseline characteristics by cohort
| Measure |
At Risk for Symptomatic AL Cardiac Amyloidosis
n=2 Participants
Patients with MGUS at risk for developing AL amyloidosis
|
At Risk for Symptomatic ATTR Cardiac Amyloidosis
n=6 Participants
Patients with biopsy proven extra-cardiac ATTR amyloidosis
|
Control Patients
n=4 Participants
Negative carpal tunnel biopsy
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.5 years
STANDARD_DEVIATION 3.5 • n=99 Participants
|
71.4 years
STANDARD_DEVIATION 5.2 • n=107 Participants
|
72 years
STANDARD_DEVIATION 6.9 • n=206 Participants
|
72 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: at the time of the PET scanPopulation: All participants had quantitative uptake of F18-Flobetapir
Number of participants with quantitative F18-florbetapir uptake above previously defined control values
Outcome measures
| Measure |
At Risk for Symptomatic AL Cardiac Amyloidosis
n=2 Participants
Patients with MGUS at risk for developing AL amyloidosis
|
At Risk for Symptomatic ATTR Cardiac Amyloidosis
n=6 Participants
Patients with biopsy proven extra-cardiac ATTR amyloidosis
|
Control Patients
n=4 Participants
Negative carpal tunnel biopsy
|
|---|---|---|---|
|
Quantitative Myocardial F18-florbetapir Uptake
|
2 Participants
|
6 Participants
|
4 Participants
|
Adverse Events
At Risk for Symptomatic AL Cardiac Amyloidosis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
At Risk for Symptomatic ATTR Cardiac Amyloidosis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place