Trial Outcomes & Findings for Asymptomatic Carotid Stenosis: Cognitive Function and Plaque Correlates (NCT NCT01353196)
NCT ID: NCT01353196
Last Updated: 2019-07-24
Results Overview
composite of multiple cognitive function test scores scores are reported as mean +/- standard deviation 0 = worst 100 = best
Recruitment status
COMPLETED
Target enrollment
170 participants
Primary outcome timeframe
2 years
Results posted on
2019-07-24
Participant Flow
Participant milestones
| Measure |
Stenosis
participants with carotid stenosis
|
no Stenosis
participants with no carotid artery stenosis
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
70
|
|
Overall Study
COMPLETED
|
71
|
59
|
|
Overall Study
NOT COMPLETED
|
29
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Asymptomatic Carotid Stenosis: Cognitive Function and Plaque Correlates
Baseline characteristics by cohort
| Measure |
Stenosis
n=100 Participants
carotid stenosis
|
no Stenosis
n=70 Participants
no carotid artery stenosis
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
74 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 10 • n=93 Participants
|
50 years
STANDARD_DEVIATION 10 • n=4 Participants
|
50 years
STANDARD_DEVIATION 10 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
167 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Composite cognitive function
|
45.5 units on a scale
STANDARD_DEVIATION 6.0 • n=93 Participants
|
47.9 units on a scale
STANDARD_DEVIATION 5.0 • n=4 Participants
|
46.0 units on a scale
STANDARD_DEVIATION 5.5 • n=27 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Participants that did not complete the study or missing key data elements were excluded from the overall analysis
composite of multiple cognitive function test scores scores are reported as mean +/- standard deviation 0 = worst 100 = best
Outcome measures
| Measure |
Stenosis
n=82 Participants
carotid stenosis
|
no Stenosis
n=62 Participants
no carotid artery stenosis
|
|---|---|---|
|
Composite Cognitive Score
|
45.5 units on a scale
Standard Deviation 6.0
|
47.9 units on a scale
Standard Deviation 5.0
|
Adverse Events
Stenosis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 18 deaths
no Stenosis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 11 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brajesh K. Lal, MD
VA Medical Center VA Maryland Health Care System, Baltimore, MD
Phone: 410-605-7000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place