Coronary Artery DiseasePhase 4NCT00209404
Iodixanol in Multidetector-Row Computed Tomography-Coronary Angiography (MDCT-CA)
A Phase 4 study testing Iodixanol 320 mg I/Ml in people with Coronary Artery Disease, run by GE Healthcare at 1 site in France.
Trial summary
Image quality in coronary artery computed tomography is influenced by the heart rate variation during the examination. The purpose of this clinical trial is to investigate the change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Iodixanol 320 mg I/Ml
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2005to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Subjects with low to moderate suspicion of coronary artery disease referred for retrospective electrocardiogram (ECG)-gated multidetector row computed tomography coronary angiography and with a heart rate >75 beats per minute (bpm) will be included.
Who cannot join
- Subjects who take medications that slow down the heart rate or present cardiac arrhythmia at rest will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Image quality in coronary artery computed tomography is influenced by the heart rate variation during the examination. The purpose of this clinical trial is to investigate the change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol). Image quality and diagnostic quality of the examination will be evaluated.
- Conditions
- Coronary Artery Disease
- Being tested
- Iodixanol 320 mg I/Ml
- Keywords
- MDCT, Coronary Artery, Heart Rate, Image Quality, Diagnostic Quality
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodixanol 320 mg I/MlDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean heart rate
Secondary outcomes (4)
Image quality
Diagnostic quality
Overall diagnostic information
Frequency and intensity of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean-Paul Antonini, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209404
- Sponsor's protocol ID
- DXV407
- Status last verified
- Oct 2007
- First submitted
- 18 Aug 2005
- Last updated
- 31 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iodixanol in Multidetector-Row Computed Tomography-Coronary Angiography (MDCT-CA)
- ClinicalTrials.gov ID
- NCT00209404
- Acronym / sponsor ID
- DXV407
- Conditions
- Coronary Artery Disease
- Keywords
- MDCT, Coronary Artery, Heart Rate, Image Quality, Diagnostic Quality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Image quality in coronary artery computed tomography is influenced by the heart rate variation during the examination. The purpose of this clinical trial is to investigate the change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol). Image quality and diagnostic quality of the examination will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with low to moderate suspicion of coronary artery disease referred for retrospective electrocardiogram (ECG)-gated multidetector row computed tomography coronary angiography and with a heart rate >75 beats per minute (bpm) will be included.
Key exclusion criteria (1 listed)
- Subjects who take medications that slow down the heart rate or present cardiac arrhythmia at rest will not be included.
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 |
|---|---|---|
| Iodixanol 320 mg I/Ml | Drug | – |
Primary outcome
Change in mean heart rate
4 secondary outcomes
Image quality
Diagnostic quality
Overall diagnostic information
Frequency and intensity of adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2007.
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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.
Jean-Paul Antonini study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iodixanol 320 mg I/Ml in people with Coronary Artery Disease, run by GE Healthcare at 1 site in France.
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 1 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 31 Oct 2007. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in mean heart rate. 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 31 Oct 2007.