Carotid Artery Disease
Conditions
Keywords
CE-U/S - Contrast-Enhanced U/S, U/S - Ultrasound, Assess effectiveness
Brief summary
The purpose of this study is to find the optimal dose from 3 different dose levels - 0.15 mL, 0.5 mL and 1.5 mL of Optison in assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group.
Interventions
DRUGOptison
Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
Sponsors
GE Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is is greater than or equal to 18 years of age. * The subjects has highly suspected or established carotid artery disease. * The subject has undergone or been referred for either unilateral or bilateral intra-arterial X-ray carotid angiography for the determination of subject management (within 30 days before or after the U/S procedure). * The subject has non-diagnostic U/S of the carotids as defined by institutional standards.
Exclusion criteria
* The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study. * The subject has a history of acute occlusion requiring medical intervention of any artery (including aorta) within 6 months of consent. * The subject has a known or suspected hypersensitivity to any of the components of Optison, blood, blood products, or albumin. * The subject has right to left, bi-directional or transient right to left cardiac shunts.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL. | Up to 10 minutes post contrast administration. | Assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group. Using the optimal dose from 3 different dose levels - 0.15 mL, 0.5 mL and 1.5 mL of Optison. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detecting the Presence of Greater Than or Equal to 50% Stenosis and Greater Than or Equal to 75% Stenosis in the Carotid Arteries When Comparing Pre-contrast to Post-contrast Ultrasound by Dose Group. | Up to 10 minutes post contrast administration. | Detecting the presence of greater than or equal to 50% stenosis and greater than or equal to 75% stenosis in the carotid arteries when comparing pre contrast to post-contrast U/S by dose group.Using the 3 different dose levels of 0.15 mL, 0.5 mL and 1.5 mL of Optison. |
Countries
United States
Participant flow
Recruitment details
21 Subjects enrolled in study. 21 subjects completed this study. 0 subjects did not complete the study.
Participants by arm
| Arm | Count |
|---|---|
| Optison Optison is a sterile non-pyrogenic suspension of perflutren for IV administration. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Optison |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 67.3 years STANDARD_DEVIATION 9.4 |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL.
Assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group. Using the optimal dose from 3 different dose levels - 0.15 mL, 0.5 mL and 1.5 mL of Optison.
Time frame: Up to 10 minutes post contrast administration.
Population: Due to difficulty enrolling subjects in all three dose levels of Optison, this study was stopped prematurely. No efficacy analyses were performed.
Secondary
Detecting the Presence of Greater Than or Equal to 50% Stenosis and Greater Than or Equal to 75% Stenosis in the Carotid Arteries When Comparing Pre-contrast to Post-contrast Ultrasound by Dose Group.
Detecting the presence of greater than or equal to 50% stenosis and greater than or equal to 75% stenosis in the carotid arteries when comparing pre contrast to post-contrast U/S by dose group.Using the 3 different dose levels of 0.15 mL, 0.5 mL and 1.5 mL of Optison.
Time frame: Up to 10 minutes post contrast administration.
Population: Due to difficulty enrolling subjects in all three dose levels of Optison , this study was stopped prematurely. No efficacy analyses were performed.