Comparison of Contrast Agents During CT Angiography

NCT01534975 | Completed Results

• 1 other identifier: Visipaque
• Study Type: interventional
• Target: 513
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effects of a certain contrast agent (iodixanol) to two other commonly used contrast agents called Iopamidol (Isovue) and iohexol (Omnipaque), on heart and kidney safety in patients undergoing a cardiac CT angiogram. The investigators will evaluate whether iodixanol 320 (Visipaque®), an iso-osmolar agent, is better tolerated (flushing, injection site pain/warmth, headache, nausea) and provides equal image quality compared with iohexol 350 (Omnipaque®) and Isovue 370 during 64-slice multidetector computed tomography angiography (MDCTA). A fourth group (Visipaque 270) will be included, using low radiation dose technology during acquisition, to evaluate image quality, tolerability, and contrast enhancement compared to both Visipaque 320 and Omnipaque and Isovue. In addition to image quality, tolerability, and contrast enhancement, the investigators will evaluate heart rate, adverse events, reimaging, costs, and patient satisfaction among all four cohorts. The study will recruit 400 participants already undergoing CT angiography and consent and randomize them to one of four groups. Each of the possible contrast agents used are commonly used for CT angiography, so the primary risk is loss of confidentiality and being asked questions about tolerability. All other facets of the study (3 lead ECG, beta blockade, nitroglycerine use, CT angiography and contrast administration) are standard of care and being done for clinical uses.

Conditions

Contrast Enhancement on Cardiac CT

Keywords

cardiac CT; enhancement; contrast; safety; image quality

Outcome Measures

Primary Outcomes (1)

• Image Quality of the CT Scans Using Different Contrast Agents

  Attenuation (HU) in the ascending aorta, standard deviation (SD) of aorta, will be measured,.

  1 year

Study Arms (4)

Iodixanol 320

ACTIVE COMPARATOR

group 1 will receive iodixanol 320 as the contrast agent during CT acquisition. this will reflect the "intervention" of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography

Diagnostic Test: contrast agent

iohexol 350

ACTIVE COMPARATOR

group 2 will receive iohexol 350 as the contrast agent during CT acquisition. this will reflect the "intervention" of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography

Diagnostic Test: contrast agent

iopamidol 370

ACTIVE COMPARATOR

group 3 will receive iopamidol 370 as the contrast agent during CT acquisition. this will reflect the "intervention" of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography

Diagnostic Test: contrast agent

iodixanol 270

ACTIVE COMPARATOR

group 4 will receive iodixanol 270 as the contrast agent during CT acquisition. this will reflect the "intervention" of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography

Diagnostic Test: contrast agent

Interventions

contrast agent DIAGNOSTIC_TEST

we are randomizing patients to different contrast agents.

Iodixanol 320; iodixanol 270; iohexol 350; iopamidol 370

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects may be included in the study if they meet all of the following criteria:
• The subject is over 18 years old.
• Subject scheduled to undergo a contrast-enhanced CCTA examination
• The subject has no contra-indication to receiving iodinated contrast administration (allergy, renal insufficiency).
• The subject has provided signed and dated informed consent

You may not qualify if:

• Subjects must be excluded from participating in this study if they meet the following criteria:
• Subjects have known contra-indication to contrast administration:
• Renal insufficiency as defined by GFR \< 50
• Known contrast allergy
• Pregnant or possibly pregnant subjects will be excluded -Women of childbearing potential will undergo urine pregnancy test prior to CT scanning.

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead
• General Electric: collaborator

Study Sites (1)

Los Angeles Biomedical Research Institute

Torrance, California, 90502, United States

Location

Related Publications (1)

• Honoris L, Zhong Y, Chu E, Rosenthal D, Li D, Lam F, Budoff MJ. Comparison of contrast enhancement, image quality and tolerability in Coronary CT angiography using 4 contrast agents: A prospective randomized trial. Int J Cardiol. 2015;186:126-8. doi: 10.1016/j.ijcard.2015.03.240. Epub 2015 Mar 19. No abstract available.

  PMID: 25818754 DERIVED

Limitations and Caveats

study was performed as outlined, sample sizes are appropriate, there were no technical problems.

Results Point of Contact

• Title: Matthew Budoff
• Organization: Los Angeles Biomedical Research Institute

mbudoff@labiomed.org

3102224107

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized cohort into 4 groups - each group with a different contrast agent (omnipaque, visipaque 280, visipaque 320, isovue)

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: February 17, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 1, 2018
• Results First Posted: March 1, 2018

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)