We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Comparison of Contrast Agents During CT Angiography (Visipaque)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01534975
Recruitment Status : Completed
First Posted : February 17, 2012
Last Update Posted : January 29, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Contrast Enhancement on Cardiac CT

Study Design

Study Type : Observational
Actual Enrollment : 360 participants
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)
Study Start Date : January 2012
Primary Completion Date : January 2013
Study Completion Date : January 2013
Groups and Cohorts

Iodixanol 320
group 1
iohexol 350
group 2
iopamidol 370
group 3
iodixanol 270
group 4

Outcome Measures

Primary Outcome Measures :
  1. image quality [ Time Frame: 1 year ]
    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 :
  1. safety [ Time Frame: 3 days ]

    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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
undergoing CT angiography for diagnostic purposes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534975

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT01534975     History of Changes
Other Study ID Numbers: Visipaque
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013

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