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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03AG042352-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The goal is to non-invasively study the metabolic processes within the aortic wall that are thought to explain progression to clinical manifestations of an aortic aneurysm.
Hypothesis is that the non-invasive imaging of Abdominal Aortic Aneurysm (AAA) with contrast ultrasound, coupled with serum biomarker measurements will allow the identification of the vulnerable aortic wall and patients who are at risk of AAA growth or rupture.
Aim#1: Prospective Contrast Ultrasound (CUS) imaging of patients with AAA to predict AAA growth and test gender differences in rate of growth and rupture.
Aim#2: Serum biomarker testing of patient with AAA. CUS findings will be correlated with serum biomarkers and AAA wall histology.
Prospective Contrast Ultrasound imaging of patients with AAA as part of a pilot feasibility study to predict AAA growth and test gender differences in rate of growth and rupture. CUS findings will be correlated with serum biomarkers and AAA wall histology. Potential significance: This study will evaluate the AAA wall and will be based on detecting areas of increased vasa vasorum density within the aneurysm wall and intraluminal thrombus, which indicate regional ischemia and inflammation of the aortic wall and propensity for weakening, enlargement or rupture. This novel evaluation of the aortic wall in patients with AAA will allow individualized treatment based on the biological potential for growth and rupture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| contrast ultrasound for patients with AAA | Active Comparator | Contrast ultrasound |
|
| contrast ultrasound for patients without arterial disease | Active Comparator | contrast enhanced ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast Ultrasound | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Annual Aneurysm Growth Rate Between Patients With and Without Micro Bubble Uptake | Prospective contrast ultrasound will be performed at regular clinically indicated timepoints. | Up to 5 years or time of aneurysm repair surgery. |
| Number of Participants With Microbubble Uptake | Microbubble uptake was determined on ultrasound evaluation of the abdominal aorta. This was agreed upon by two reading physicians. | At the first follow-up evaluation at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Value of Systemic Inflammatory Serum Biomarkers | 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. | baseline, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rabih Chaer, MD | UPMC UPP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center, Division of Vascular Surgery | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Annual Aneurysm Growth Rate Between Patients With and Without Micro Bubble Uptake | Prospective contrast ultrasound will be performed at regular clinically indicated timepoints. | Annual aneurysm growth rate only relevant for patients with aneurysm disease | Posted | Mean | Standard Deviation | mm/year | Up to 5 years or time of aneurysm repair surgery. |
|
Adverse data were collected from the time of contrast administration through study completion (an average of 6 months), for all patients.
The definitions do not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rabih Chaer | University of Pittsburgh Medical Center | 4128023025 | chaerra@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2023 | Jul 3, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C042852 | perflutren |
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|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Participants With Microbubble Uptake | Microbubble uptake was determined on ultrasound evaluation of the abdominal aorta. This was agreed upon by two reading physicians. | Microbubble Uptake was only evaluated in patients with aneurysm disease as patients without aneurysm disease do not have micro bubble uptake. | Posted | Count of Participants | Participants | At the first follow-up evaluation at 6 months |
|
|
|
| Secondary | Mean Value of Systemic Inflammatory Serum Biomarkers | 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. | 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. | Posted | Mean | 95% Confidence Interval | pg/ml | baseline, 6 months |
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | 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. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D001018 |
| Aortic Diseases |
| C Reactive Protein |
|
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| Interferon |
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| Osteoprotegrin (at 6 months) |
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| C Reactive Protein (at 6 months) |
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| Interferon (at 6 months) |
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|