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Comparison of Contrast Agents During CT Angiography (Visipaque)

This study has been completed.
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT01534975
First received: February 14, 2012
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Contrast Enhancement on Cardiac CT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Prospective, Single-Center Double-Blind Randomized Study in Subjects Undergoing Coronary Computed Tomography Angiography (CCTA) Examination (VISIPAQUE Randomized Study)

Resource links provided by NLM:

MedlinePlus related topics: CT Scans
Drug Information available for: Iodixanol
U.S. FDA Resources

Further study details as provided by Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • image quality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Attenuation (HU) in the ascending aorta, left ventricular (LV) cavity and LV myocardium (septal and lateral wall) and image noise, standard deviation (SD) of aorta, will be measured, as well as mean change in heart rate over administration time and scan time.


Secondary Outcome Measures:
  • safety [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

    We will also assess adverse events and complications, including delayed reactions among the four contrast agent groups.

    Measurements include: image quality, pt comfort, HR, contrast enhancement, re-image, cost, pt satisfaction, AEs including DARs.



Enrollment: 360
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Iodixanol 320
group 1
iohexol 350
group 2
iopamidol 370
group 3
iodixanol 270
group 4

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

undergoing CT angiography for diagnostic purposes

Criteria

Inclusion Criteria:

Subjects may be included in the study if they meet all of the following criteria:

  1. The subject is over 18 years old.
  2. Subject scheduled to undergo a contrast-enhanced CCTA examination
  3. The subject has no contra-indication to receiving iodinated contrast administration (allergy, renal insufficiency).
  4. The subject has provided signed and dated informed consent

Exclusion criteria:

Subjects must be excluded from participating in this study if they meet the following criteria:

  1. Subjects have known contra-indication to contrast administration:

    • Renal insufficiency as defined by GFR < 50
    • Known contrast allergy
  2. Pregnant or possibly pregnant subjects will be excluded -Women of childbearing potential will undergo urine pregnancy test prior to CT scanning.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534975

Locations
United States, California
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90502
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
General Electric
  More Information

No publications provided

Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT01534975     History of Changes
Other Study ID Numbers: Visipaque
Study First Received: February 14, 2012
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Los Angeles Biomedical Research Institute:
cardiac CT
enhancement
contrast
safety
image quality

ClinicalTrials.gov processed this record on May 22, 2013