Coronary Computed Tomographic AngiographyPhase 3NCT02171247
Comparison of Isovue 370 vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)
A Phase 3 study testing Isovue 370 and Visipaque 320 in people with Coronary Computed Tomographic Angiography, run by Duke University.
Trial summary
Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in the body as an alternative to directly injecting contrast into the vessels and taking pictures. Different types of intravenous (into the vein, IV) contrast are available to fill the vessels and make them easier to see. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Computed Tomographic Angiography
- What is being tested?
- Isovue 370 and Visipaque 320
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Dec 2010
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients who are referred for coronary CTA for suspected or known coronary artery disease
Who cannot join
- creatinine greater than 2.0
- allergy to contrast media
- patients under the age of 18
- women who are pregnant or breast feeding
- patients with cardiac arrhythmia will also be excluded
About this study
Official title: Comparison of the Use of High Iodine Concentration Contrast Material (Isovue 370) vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)
Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in the body as an alternative to directly injecting contrast into the vessels and taking pictures. Different types of intravenous (into the vein, IV) contrast are available to fill the vessels and make them easier to see. The purpose of the study is to determine the best type of contrast for this scan.
- Being tested
- Isovue 370, Visipaque 320
- Keywords
- coronary computed tomographic angiography, contrast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isovue 370Drug
Isovue 370 is a contrast agent with increased iodine concentration.
Visipaque 320Drug
Visipaque 320 is standard protocol.
| Study group | Role | What they receive |
|---|---|---|
| Isovue 370 | Active comparator | Isovue 370 is a contrast agent with increased iodine concentration. Receives: Drug: Isovue 370 |
| Visipaque 320 | Active comparator | Standard protocol is Visipaque 320. Receives: Drug: Visipaque 320 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast to Noise Ratio
Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation - myocardium attenuation) / SD of mean noise attenuation.
Measured: during scan, approximately 3 hours
Image Quality
Depiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels.
Measured: during scan, approximately 3 hours
Motion Artifact
The outcome will be measured by individual scores. The scores from multiple readers will be averaged.
Measured: during scan, approximately 3 hours
Attenuation of the Ascending Aorta and Coronary Arteries
The investigator will measure the length of visualized coronary artery for the left anterior descending, left circumflex and right coronary arteries as a way of quantifying visualization of distal coronary segments.
Measured: during scan, approximately 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startApr 2008
- Primary completionDec 2010
- Study completionDec 2010
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.
- Other trials for Coronary Computed Tomographic AngiographyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel T Boll, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171247
- Sponsor's protocol ID
- Pro00004492
- Status last verified
- Jul 2014
- First submitted
- 12 Jun 2014
- Last updated
- 15 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Use of High Iodine Concentration Contrast Material (Isovue 370) vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)
- ClinicalTrials.gov ID
- NCT02171247
- Acronym / sponsor ID
- Pro00004492
- Keywords
- coronary computed tomographic angiography, contrast
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in the body as an alternative to directly injecting contrast into the vessels and taking pictures. Different types of intravenous (into the vein, IV) contrast are available to fill the vessels and make them easier to see. The purpose of the study is to determine the best type of contrast for this scan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isovue 370 | Active comparator | Drug: Isovue 370Isovue 370 is a contrast agent with increased iodine concentration. |
| Visipaque 320 | Active comparator | Drug: Visipaque 320Standard protocol is Visipaque 320. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients who are referred for coronary CTA for suspected or known coronary artery disease
Key exclusion criteria (5 listed)
- creatinine greater than 2.0
- allergy to contrast media
- patients under the age of 18
- women who are pregnant or breast feeding
- patients with cardiac arrhythmia will also be excluded
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 |
|---|---|---|
| Isovue 370Isovue 370 is a contrast agent with increased iodine concentration. | Drug | Isovue 370 |
| Visipaque 320Visipaque 320 is standard protocol. | Drug | Visipaque 320 |
Primary outcome
Contrast to Noise Ratio
Time frame: during scan, approximately 3 hours
Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation - myocardium attenuation) / SD of mean noise attenuation.
Image Quality
Time frame: during scan, approximately 3 hours
Depiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels.
Motion Artifact
Time frame: during scan, approximately 3 hours
The outcome will be measured by individual scores. The scores from multiple readers will be averaged.
Attenuation of the Ascending Aorta and Coronary Arteries
Time frame: during scan, approximately 3 hours
The investigator will measure the length of visualized coronary artery for the left anterior descending, left circumflex and right coronary arteries as a way of quantifying visualization of distal coronary segments.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Coronary Computed Tomographic Angiography
Recruiting
Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
Computed Tomography Angiography, Coronary Artery Disease
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
RecruitingObservational study
Coronary Myocardial Bridge and Coronary Plaques on MDCT
Myocardial Bridging, Coronary Atherosclerosis
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
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.
Daniel T Boll, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isovue 370 and Visipaque 320 in people with Coronary Computed Tomographic Angiography, run by Duke University.
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 1 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 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2014). 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?
Contrast to Noise Ratio (time frame: during scan, approximately 3 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2014.