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Computed Tomography Arteriograms (CTA) Volume Dose Reduction Study

Primary Purpose

Aortic Aneurysm, Contrast Induced Nephropathy, Aortic and Arterial Anomalies

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Dose Contrast (Omnipaque) 40mL
Low Dose Contrast (Omnipaque) 50 mL
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aortic Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any adult patient scheduled for a computed tomographic arteriogram (CTA) of the chest or chest, abdomen and pelvis who had undergone a prior CTA performed with the standard contrast dose (100 mL) at this institution will be included in the study
  • The follow-up scan will be routine standard of care, no emergency imaging patient will be approached for this research

Exclusion Criteria:

  • Patients with no prior CTA imaging for comparison
  • Any pediatric patient (age <18)
  • BMI >40
  • Inability to follow instructions
  • Allergy to intravenous contrast
  • GFR less than 30 mL/min/1.73 m2

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low Dose Contrast (40mL)

Low Dose Contrast (50mL)

Arm Description

CTA of the chest: 40 mL of intravenous contrast at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date.

CTA of the abdomen OR or CTA of the chest and abdomen or CTA of the abdomen and pelvis or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date.

Outcomes

Primary Outcome Measures

Ascending Sinotubular Junction Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. Measurement was taken at the ascending aorta near the sinotubular junction.
Descending Thoracic Aorta Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation.
Celiac Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the proximal abdominal aorta at the level of the celiac axis.
Burfication Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation.
Right Common Femoral Artery Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery.
Left Common Femoral Artery Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery.
CTA Vessel Opacification Grading 1
5 Point Grading Scale was used to determine CTA Vessel Opacification by a Board Certified Radiologist. Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic. Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic. Moderate opacification of the lumen of the vessel. Diagnostic study. Good opacification of the lumen of the vessel. Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel.
CTA Vessel Opacification Grading 2
5 Point Grading Scale was used to determine CTA Vessel Opacification by a second Board Certified Radiologist. Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic. Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic. Moderate opacification of the lumen of the vessel. Diagnostic Good opacification of the lumen of the vessel. Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2016
Last Updated
May 17, 2019
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02669784
Brief Title
Computed Tomography Arteriograms (CTA) Volume Dose Reduction Study
Official Title
Does Reduction in Contrast Administration Dose in Computed Tomography Arteriograms Degrade Image Quality? A Single Institutional Review of an Ultra-low Contrast Dose Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to determine if the dose of contrast (Omnipaque) administered for Computed Tomography Arteriograms (CTA) can be reduced without degradation of image quality. The hypothesis is that there is no difference in image quality using ultra-low dose contrast in CTA exams compared to routine, standard of care dose exams.
Detailed Description
Any adult patient age 18 and above, scheduled for routine CTA (Computed Tomography Arteriograms) of the chest or chest, abdomen and pelvis meeting inclusion criteria and not meeting any exclusion criteria will be included in the study. The patient will be administered a low dose of intravenous contrast based on the study examination as described below. CTA of the chest: 40 mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. CTA of the chest and abdomen or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast (Omnipaque) at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. Following the examination, the primary investigator (PI) or team members will evaluate the images obtained with low contrast dose and each patient's prior CTA examination performed with routine contrast dose, 100mL at a rate of 4mL/sec. This will be done by quantitative and qualitative measures. For the quantitative portion, the PI or team members will place regions of interest on predetermined arterial locations to obtain measure the degree of opacification. For qualitative measurement, the images will be presented in a blind fashion to two thoracic trained board certified radiologists and a board certified interventional radiologist to determine the quality of the images based on a Likert numerical scale. Qualitative and quantitative data for the images obtained with low contrast dose and those for the prior CTA examinations performed with routine contrast dose will be compared. This data along with details of the scan protocol (dose, dose rate, scanning parameters etc.) and demographic data (such as sex, age and BMI at the time of examination) will be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Contrast Induced Nephropathy, Aortic and Arterial Anomalies

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose Contrast (40mL)
Arm Type
Active Comparator
Arm Description
CTA of the chest: 40 mL of intravenous contrast at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date.
Arm Title
Low Dose Contrast (50mL)
Arm Type
Active Comparator
Arm Description
CTA of the abdomen OR or CTA of the chest and abdomen or CTA of the abdomen and pelvis or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date.
Intervention Type
Drug
Intervention Name(s)
Low Dose Contrast (Omnipaque) 40mL
Intervention Description
The patient will be administered a low dose, 40mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec based on the area of the body being scanned (chest versus chest and abdomen versus chest, abdomen and pelvis). This will be compared to the patient's prior examination performed with 100mL of intravenous contrast at a rate of 4mL/sec.
Intervention Type
Drug
Intervention Name(s)
Low Dose Contrast (Omnipaque) 50 mL
Intervention Description
The patient will be administered a low dose, 50mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec based on the area of the body being scanned (chest versus chest and abdomen versus chest, abdomen and pelvis). This will be compared to the patient's prior examination performed with 100mL of intravenous contrast at a rate of 4mL/sec.
Primary Outcome Measure Information:
Title
Ascending Sinotubular Junction Measurement
Description
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. Measurement was taken at the ascending aorta near the sinotubular junction.
Time Frame
At 30 days
Title
Descending Thoracic Aorta Measurement
Description
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation.
Time Frame
30 days
Title
Celiac Measurement
Description
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the proximal abdominal aorta at the level of the celiac axis.
Time Frame
30 days
Title
Burfication Measurement
Description
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation.
Time Frame
30 days
Title
Right Common Femoral Artery Measurement
Description
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery.
Time Frame
30 days
Title
Left Common Femoral Artery Measurement
Description
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery.
Time Frame
30 days
Title
CTA Vessel Opacification Grading 1
Description
5 Point Grading Scale was used to determine CTA Vessel Opacification by a Board Certified Radiologist. Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic. Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic. Moderate opacification of the lumen of the vessel. Diagnostic study. Good opacification of the lumen of the vessel. Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel.
Time Frame
30 days
Title
CTA Vessel Opacification Grading 2
Description
5 Point Grading Scale was used to determine CTA Vessel Opacification by a second Board Certified Radiologist. Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic. Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic. Moderate opacification of the lumen of the vessel. Diagnostic Good opacification of the lumen of the vessel. Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any adult patient scheduled for a computed tomographic arteriogram (CTA) of the chest or chest, abdomen and pelvis who had undergone a prior CTA performed with the standard contrast dose (100 mL) at this institution will be included in the study The follow-up scan will be routine standard of care, no emergency imaging patient will be approached for this research Exclusion Criteria: Patients with no prior CTA imaging for comparison Any pediatric patient (age <18) BMI >40 Inability to follow instructions Allergy to intravenous contrast GFR less than 30 mL/min/1.73 m2
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26937437
Citation
Seehofnerova A, Kok M, Mihl C, Douwes D, Sailer A, Nijssen E, de Haan MJ, Wildberger JE, Das M. Feasibility of low contrast media volume in CT angiography of the aorta. Eur J Radiol Open. 2015 Apr 28;2:58-65. doi: 10.1016/j.ejro.2015.03.001. eCollection 2015.
Results Reference
background
PubMed Identifier
12598026
Citation
Rubin GD. MDCT imaging of the aorta and peripheral vessels. Eur J Radiol. 2003 Mar;45 Suppl 1:S42-9. doi: 10.1016/s0720-048x(03)00036-6.
Results Reference
background
PubMed Identifier
15547209
Citation
Gleeson TG, Bulugahapitiya S. Contrast-induced nephropathy. AJR Am J Roentgenol. 2004 Dec;183(6):1673-89. doi: 10.2214/ajr.183.6.01831673. No abstract available.
Results Reference
background
PubMed Identifier
26047631
Citation
Vanommeslaeghe F, De Mulder E, Van de Bruaene C, Van de Bruaene L, Lameire N, Van Biesen W. Selecting a strategy for prevention of contrast-induced nephropathy in clinical practice: an evaluation of different clinical practice guidelines using the AGREE tool. Nephrol Dial Transplant. 2015 Aug;30(8):1300-6. doi: 10.1093/ndt/gfv220. Epub 2015 Jun 4.
Results Reference
background
PubMed Identifier
16763513
Citation
Meschi M, Detrenis S, Musini S, Strada E, Savazzi G. Facts and fallacies concerning the prevention of contrast medium-induced nephropathy. Crit Care Med. 2006 Aug;34(8):2060-8. doi: 10.1097/01.CCM.0000227651.73500.BA.
Results Reference
background
PubMed Identifier
17291156
Citation
Walsh SR, Tang T, Gaunt ME, Boyle JR. Contrast-induced nephropathy. J Endovasc Ther. 2007 Feb;14(1):92-100. doi: 10.1583/06-2035.1.
Results Reference
background
PubMed Identifier
2010458
Citation
Gussenhoven MJ, Ravensbergen J, van Bockel JH, Feuth JD, Aarts JC. Renal dysfunction after angiography; a risk factor analysis in patients with peripheral vascular disease. J Cardiovasc Surg (Torino). 1991 Jan-Feb;32(1):81-6.
Results Reference
background
PubMed Identifier
18295101
Citation
Diehm N, Pena C, Benenati JF, Tsoukas AI, Katzen BT. Adequacy of an early arterial phase low-volume contrast protocol in 64-detector computed tomography angiography for aortoiliac aneurysms. J Vasc Surg. 2008 Mar;47(3):492-8. doi: 10.1016/j.jvs.2007.11.004.
Results Reference
background
PubMed Identifier
22683247
Citation
Viteri-Ramirez G, Garcia-Lallana A, Simon-Yarza I, Broncano J, Ferreira M, Pueyo JC, Villanueva A, Bastarrika G. Low radiation and low-contrast dose pulmonary CT angiography: Comparison of 80 kVp/60 ml and 100 kVp/80 ml protocols. Clin Radiol. 2012 Sep;67(9):833-9. doi: 10.1016/j.crad.2011.11.016. Epub 2012 Jun 8.
Results Reference
background
PubMed Identifier
23169715
Citation
Wu CC, Lee EW, Suh RD, Levine BS, Barack BM. Pulmonary 64-MDCT angiography with 30 mL of IV contrast material: vascular enhancement and image quality. AJR Am J Roentgenol. 2012 Dec;199(6):1247-51. doi: 10.2214/AJR.12.8739.
Results Reference
background

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Computed Tomography Arteriograms (CTA) Volume Dose Reduction Study

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