Contrast Enhancement on Cardiac CTVisipaqueNCT01534975
Comparison of Contrast Agents During CT Angiography
A study testing contrast agent in people with Contrast Enhancement on Cardiac CT, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Contrast Enhancement on Cardiac CT
- What is being tested?
- contrast agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 513 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Biomedical Research Institute
Torrance, California, 90502
About this study
Official title: A Prospective, Single-Center Double-Blind Randomized Study in Subjects Undergoing Coronary Computed Tomography Angiography (CCTA) Examination (VISIPAQUE Randomized Study)
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.
Read the detailed description
CTA infusion is administered using a 5 ml/sec IV iodinated contrast infusion. 50-70 ml of iodinated contrast is used for the scan depending on the patient's body habitus. The total contrast dose must not exceed 70 ml. An automated bolus tracking feature (SmartPrep, GE Healthcare, Milwaukee, USA) is used to judge contrast bolus arrival and optimize image quality. Patients will be asked to hold their breaths during scanning for up to 10 seconds. A Field of View (FOV) of 25 cm is adjusted to include the heart from below the carina to just below diaphragm. The aorta will be included in the FOV to exclude aortic pathology (ie. dissection, aneurysm, etc.). For patients in sinus rhythm, prospective ECG gating centered at 75% of the R-R interval is used while those in Atrial fibrillation or HR >65 despite oral and IV medications, a retrospective gating is used. The following parameters are used Tube voltage = 100-120kV (based on body habitus), tube current = 400 mA, gantry rotation speed = 0.35 seconds, slice thickness = 0.625 mm, rows = 64, coverage = 128-160 mm.
Estimated radiation dose is = 2-5 mSv dependent on BMI, cardiac height and heart rate. A post acquisition software (Adaptive Statistical Iterative Reconstruction, GE healthcare, Milwaukee, USA) is used to reduce pixel noise standard deviation (noise) by 30 percent and allows for reduced mA in the acquisition while still yielding diagnostic images, thereby reducing total dose required. At the conclusion of each acquisition, technologists collect a survey of patient satisfaction quantifying side effects of different contrasts: flushing, headache, nausea, and pain at injection site as mild, moderate or severe.
Advantage Workstation 4.6 software (GE healthcare, Milwaukee, USA) is used for post acquisition processing. Readers, who are blinded to the type of contrast media used, assess image quality by measuring contrast enhancement in aorta, LV myocardium, left main, proximal Left Anterior Descending artery, proximal and distal Right Coronary arteries. Subjects with coronary artery bypass graft and stents are excluded. Heart rate (HR) variability during the scan is also evaluated. A comparison of the degree of contrast enhancement of the coronary lumen as well as the differences for each of the four contrast agents will be measured and reported, stratified by 100 kVp and 120 kVp acquisition. The image quality of 17 coronary artery segments will be graded by two cardiologists in consensus with the use of a four-point scale (1= excellent, 2=good, 3=fair , 4= poor enhancement) blinded to contrast agent administration.
Statistical Analysis:
All analysis is conducted using SPSS 18.0 for window (SPSS Inc., Chicago, IL, USA). Comparisons between groups are performed using a Student t-test for continuous variables with normal distributions and the Mann-Whitney U test for continuous variables with non-normal distributions. Categorical variables were analyzed by means of χ2 analysis. Correlation between minimum HR and maximum HR was calculated with the Pearson correlation coefficient. The Cochran-Mantel-Haenszel test was used for analyzing the difference in visual quality between two groups.
- Conditions
- Contrast Enhancement on Cardiac CT
- Being tested
- contrast agent
- Keywords
- cardiac CT, enhancement, contrast, safety, image quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast agentDiagnostic test
we are randomizing patients to different contrast agents.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: contrast agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality of the CT Scans Using Different Contrast Agents
Attenuation (HU) in the ascending aorta, standard deviation (SD) of aorta, will be measured,.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contrast Enhancement on Cardiac CTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized cohort into 4 groups - each group with a different contrast agent (omnipaque, visipaque 280, visipaque 320, isovue)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534975
- Sponsor's protocol ID
- Visipaque
- Acronym
- Visipaque
- Status last verified
- Mar 2017
- First submitted
- 14 Feb 2012
- Last updated
- 1 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25818754
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center Double-Blind Randomized Study in Subjects Undergoing Coronary Computed Tomography Angiography (CCTA) Examination (VISIPAQUE Randomized Study)
- ClinicalTrials.gov ID
- NCT01534975
- Acronym / sponsor ID
- Visipaque / Visipaque
- Conditions
- Contrast Enhancement on Cardiac CT
- Keywords
- cardiac CT, enhancement, contrast, safety, image quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Posted 1 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CTA infusion is administered using a 5 ml/sec IV iodinated contrast infusion. 50-70 ml of iodinated contrast is used for the scan depending on the patient's body habitus. The total contrast dose must not exceed 70 ml. An automated bolus tracking feature (SmartPrep, GE Healthcare, Milwaukee, USA) is used to judge contrast bolus arrival and optimize image quality. Patients will be asked to hold their breaths during scanning for up to 10 seconds. A Field of View (FOV) of 25 cm is adjusted to include the heart from below the carina to just below diaphragm. The aorta will be included in the FOV to exclude aortic pathology (ie. dissection, aneurysm, etc.). For patients in sinus rhythm, prospective ECG gating centered at 75% of the R-R interval is used while those in Atrial fibrillation or HR >65 despite oral and IV medications, a retrospective gating is used. The following parameters are used Tube voltage = 100-120kV (based on body habitus), tube current = 400 mA, gantry rotation speed = 0.35 seconds, slice thickness = 0.625 mm, rows = 64, coverage = 128-160 mm.
Estimated radiation dose is = 2-5 mSv dependent on BMI, cardiac height and heart rate. A post acquisition software (Adaptive Statistical Iterative Reconstruction, GE healthcare, Milwaukee, USA) is used to reduce pixel noise standard deviation (noise) by 30 percent and allows for reduced mA in the acquisition while still yielding diagnostic images, thereby reducing total dose required. At the conclusion of each acquisition, technologists collect a survey of patient satisfaction quantifying side effects of different contrasts: flushing, headache, nausea, and pain at injection site as mild, moderate or severe.
Advantage Workstation 4.6 software (GE healthcare, Milwaukee, USA) is used for post acquisition processing. Readers, who are blinded to the type of contrast media used, assess image quality by measuring contrast enhancement in aorta, LV myocardium, left main, proximal Left Anterior Descending artery, proximal and distal Right Coronary arteries. Subjects with coronary artery bypass graft and stents are excluded. Heart rate (HR) variability during the scan is also evaluated. A comparison of the degree of contrast enhancement of the coronary lumen as well as the differences for each of the four contrast agents will be measured and reported, stratified by 100 kVp and 120 kVp acquisition. The image quality of 17 coronary artery segments will be graded by two cardiologists in consensus with the use of a four-point scale (1= excellent, 2=good, 3=fair , 4= poor enhancement) blinded to contrast agent administration.
Statistical Analysis:
All analysis is conducted using SPSS 18.0 for window (SPSS Inc., Chicago, IL, USA). Comparisons between groups are performed using a Student t-test for continuous variables with normal distributions and the Mann-Whitney U test for continuous variables with non-normal distributions. Categorical variables were analyzed by means of χ2 analysis. Correlation between minimum HR and maximum HR was calculated with the Pearson correlation coefficient. The Cochran-Mantel-Haenszel test was used for analyzing the difference in visual quality between two groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- randomized cohort into 4 groups - each group with a different contrast agent (omnipaque, visipaque 280, visipaque 320, isovue)
| Arm | Type | Receives |
|---|---|---|
| Iodixanol 320 | Active comparator | Diagnostic Test: contrast agentgroup 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 |
| iohexol 350 | Active comparator | Diagnostic Test: contrast agentgroup 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 |
| iopamidol 370 | Active comparator | Diagnostic Test: contrast agentgroup 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 |
| iodixanol 270 | Active comparator | Diagnostic Test: contrast agentgroup 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Subjects must be excluded from participating in this study if they meet the following criteria:
- Subjects have known contra-indication to contrast administration:
- Pregnant or possibly pregnant subjects will be excluded -Women of childbearing potential will undergo urine pregnancy test prior to CT scanning.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contrast agentwe are randomizing patients to different contrast agents. | Diagnostic test | Iodixanol 320, iodixanol 270, iohexol 350, iopamidol 370 |
Primary outcome
Image Quality of the CT Scans Using Different Contrast Agents
Time frame: 1 year
Attenuation (HU) in the ascending aorta, standard deviation (SD) of aorta, will be measured,.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25818754Honoris 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contrast agent in people with Contrast Enhancement on Cardiac CT, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Quality of the CT Scans Using Different Contrast Agents (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01534975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.