Trial Outcomes & Findings for Non-invasive Computer-Aided Phenotyping of Vasculopathy (NCT NCT02143102)
NCT ID: NCT02143102
Last Updated: 2018-08-06
Results Overview
Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)
Recruitment status
COMPLETED
Target enrollment
125 participants
Primary outcome timeframe
Assessed on tissue samples collected within 30 days of non-invasive imaging
Results posted on
2018-08-06
Participant Flow
Participant milestones
| Measure |
Development Set
Data from subjects in the training set will be utilized to further develop the vascuCAPTM classifiers.
|
Testing Set
Data from subjects in the testing set will be used to assess the study endpoints.
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
28
|
|
Overall Study
COMPLETED
|
86
|
28
|
|
Overall Study
NOT COMPLETED
|
11
|
0
|
Reasons for withdrawal
| Measure |
Development Set
Data from subjects in the training set will be utilized to further develop the vascuCAPTM classifiers.
|
Testing Set
Data from subjects in the testing set will be used to assess the study endpoints.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
0
|
Baseline Characteristics
Non-invasive Computer-Aided Phenotyping of Vasculopathy
Baseline characteristics by cohort
| Measure |
Development Set
n=86 Participants
Data from subjects in the training set will be utilized to further develop the vascuCAP measurements.
|
Testing Set
n=28 Participants
Data from subjects in the testing set will be used to assess the study endpoints.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 11 • n=5 Participants
|
66.6 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
66.4 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
82 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed on tissue samples collected within 30 days of non-invasive imagingPerformance of measurements was assessed by estimating the bias (the difference between the measurement and histology)
Outcome measures
| Measure |
Testing Set
n=28 Participants
Data from subjects in the testing set will be used to assess the study endpoints.
|
Full
n=114 Participants
Pooled results for final estimation
|
|---|---|---|
|
Measurement Bias of Calcification Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.
|
-0.47 mm2
Interval -1.75 to 0.41
|
.07 mm2
Interval -0.22 to 0.42
|
PRIMARY outcome
Timeframe: Assessed on tissue samples collected within 30 days of non-invasive imagingPerformance of measurements was assessed by estimating the bias (the difference between the measurement and histology)
Outcome measures
| Measure |
Testing Set
n=28 Participants
Data from subjects in the testing set will be used to assess the study endpoints.
|
Full
n=114 Participants
Pooled results for final estimation
|
|---|---|---|
|
Measurement Bias of Lipid-rich Necrotic Core Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.
|
1.26 mm2
Interval 0.12 to 2.51
|
.87 mm2
Interval -0.18 to 1.9
|
Adverse Events
Development Set
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Testing Set
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