Computed Tomography Arteriograms (CTA) Volume Dose Reduction Study

NCT02669784 | Completed Results

• 1 other identifier: 3932
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Aneurysm; Contrast Induced Nephropathy; Aortic and Arterial Anomalies

Outcome Measures

Primary Outcomes (8)

• 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.

  At 30 days

• 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.

  30 days

• 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.

  30 days

• 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.

  30 days

• 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.

  30 days

• 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.

  30 days

• CTA Vessel Opacification Grading 1

  5 Point Grading Scale was used to determine CTA Vessel Opacification by a Board Certified Radiologist. 1. Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic. 2. Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic. 3. Moderate opacification of the lumen of the vessel. Diagnostic study. 4. Good opacification of the lumen of the vessel. 5. Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel.

  30 days

• CTA Vessel Opacification Grading 2

  5 Point Grading Scale was used to determine CTA Vessel Opacification by a second Board Certified Radiologist. 1. Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic. 2. Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic. 3. Moderate opacification of the lumen of the vessel. Diagnostic 4. Good opacification of the lumen of the vessel. 5. Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel.

  30 days

Study Arms (2)

Low Dose Contrast (40mL)

ACTIVE COMPARATOR

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.

Drug: Low Dose Contrast (Omnipaque) 40mL

Low Dose Contrast (50mL)

ACTIVE COMPARATOR

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.

Drug: Low Dose Contrast (Omnipaque) 50 mL

Interventions

Low Dose Contrast (Omnipaque) 40mL DRUG

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.

Low Dose Contrast (40mL)

Low Dose Contrast (Omnipaque) 50 mL DRUG

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.

Low Dose Contrast (50mL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (10)

• 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.

  PMID: 26937437 BACKGROUND

• 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.

  PMID: 12598026 BACKGROUND

• 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.

  PMID: 15547209 BACKGROUND

• 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.

  PMID: 26047631 BACKGROUND

• 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.

  PMID: 16763513 BACKGROUND

• 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.

  PMID: 17291156 BACKGROUND

• 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.

  PMID: 2010458 BACKGROUND

• 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.

  PMID: 18295101 BACKGROUND

• 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.

  PMID: 22683247 BACKGROUND

• 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.

  PMID: 23169715 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm

Interventions

Contrast Media; Iohexol

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Rekha Cherian, M.D.
• Organization: Milton S. Hershey Medical Center

rcherian@pennstatehealth.psu.edu

717-531-6735

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: February 1, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: November 1, 2018
• Last Updated: June 11, 2019
• Results First Posted: June 11, 2019

Record last verified: 2019-05

Locations

US (1)