Trial Outcomes & Findings for Evaluation of Predictors of Aortic Aneurysm Growth and Rupture (NCT NCT02022436)
NCT ID: NCT02022436
Last Updated: 2023-11-13
Results Overview
Prospective contrast ultrasound will be performed at regular clinically indicated timepoints.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Up to 5 years or time of aneurysm repair surgery.
Results posted on
2023-11-13
Participant Flow
Participant milestones
| Measure |
Contrast Ultrasound for Patients With AAA
Contrast ultrasound
contrast ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
Contrast Ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
|
Contrast Ultrasound for Patients Without Arterial Disease
contrast enhanced ultrasound
contrast ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
Contrast Ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
7
|
|
Overall Study
COMPLETED
|
59
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Predictors of Aortic Aneurysm Growth and Rupture
Baseline characteristics by cohort
| Measure |
Contrast Ultrasound for Patients With AAA
n=59 Participants
Contrast ultrasound
contrast ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
Contrast Ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
|
Contrast Ultrasound for Patients Without Arterial Disease
n=7 Participants
contrast enhanced ultrasound
contrast ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
Contrast Ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
41 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
67.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
7 participants
n=7 Participants
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 years or time of aneurysm repair surgery.Population: Annual aneurysm growth rate only relevant for patients with aneurysm disease
Prospective contrast ultrasound will be performed at regular clinically indicated timepoints.
Outcome measures
| Measure |
Contrast Ultrasound for Patients With Aneurysm Disease
n=59 Participants
Contrast ultrasound
contrast ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
Contrast Ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
|
Contrast Ultrasound for Patients Without Arterial Disease
contrast enhanced ultrasound
Contrast Ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
|
|---|---|---|
|
Annual Aneurysm Growth Rate Between Patients With and Without Micro Bubble Uptake
Microbubble Uptake
|
3.0 mm/year
Standard Deviation 3.1
|
—
|
|
Annual Aneurysm Growth Rate Between Patients With and Without Micro Bubble Uptake
No Microbubble Uptake
|
3.2 mm/year
Standard Deviation 3.1
|
—
|
PRIMARY outcome
Timeframe: At the first follow-up evaluation at 6 monthsPopulation: Microbubble Uptake was only evaluated in patients with aneurysm disease as patients without aneurysm disease do not have micro bubble uptake.
Microbubble uptake was determined on ultrasound evaluation of the abdominal aorta. This was agreed upon by two reading physicians.
Outcome measures
| Measure |
Contrast Ultrasound for Patients With Aneurysm Disease
n=59 Participants
Contrast ultrasound
contrast ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
Contrast Ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
|
Contrast Ultrasound for Patients Without Arterial Disease
contrast enhanced ultrasound
Contrast Ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
|
|---|---|---|
|
Number of Participants With Microbubble Uptake
|
36 Participants
|
—
|
SECONDARY outcome
Timeframe: baseline, 6 monthsPopulation: For patients without arterial disease, serum biomarkers were only obtained at baseline; no follow-up visits occurred and therefore no further biomarker testing was done.
Systemic serum biomarkers of AAA will be measured. These markers are circulating levels of C Reactive Protein, cytokines and osteoprotegerin. Serum markers will be drawn at baseline and at the next follow-up visit which is 6 months after the index visit.
Outcome measures
| Measure |
Contrast Ultrasound for Patients With Aneurysm Disease
n=59 Participants
Contrast ultrasound
contrast ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
Contrast Ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
|
Contrast Ultrasound for Patients Without Arterial Disease
n=7 Participants
contrast enhanced ultrasound
Contrast Ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
|
|---|---|---|
|
Mean Value of Systemic Inflammatory Serum Biomarkers
Interferon (at 6 months)
|
5.1 pg/ml
Interval 3.5 to 6.6
|
—
|
|
Mean Value of Systemic Inflammatory Serum Biomarkers
Osteoprotegrin
|
225.5 pg/ml
Interval 142.7 to 308.3
|
214.8 pg/ml
Interval 134.7 to 294.9
|
|
Mean Value of Systemic Inflammatory Serum Biomarkers
C Reactive Protein
|
7090.3 pg/ml
Interval 3619.0 to 10561.6
|
1843.0 pg/ml
Interval 1017.2 to 2668.8
|
|
Mean Value of Systemic Inflammatory Serum Biomarkers
Interferon
|
4.2 pg/ml
Interval 3.3 to 4.8
|
2.4 pg/ml
Interval 1.8 to 2.9
|
|
Mean Value of Systemic Inflammatory Serum Biomarkers
Osteoprotegrin (at 6 months)
|
257.4 pg/ml
Interval 225.0 to 289.8
|
—
|
|
Mean Value of Systemic Inflammatory Serum Biomarkers
C Reactive Protein (at 6 months)
|
7808.0 pg/ml
Interval 220.2 to 15395.8
|
—
|
Adverse Events
Contrast Ultrasound for Patients With AAA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Contrast Ultrasound for Patients Without Arterial Disease
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