Coronary Artery DiseaseVOLCANIC-CTANCT03179592
VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography
An observational study of Coronary Artery Disease and Cardiovascular Diseases, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to prospectively evaluate the effectiveness of low-volume contrast media (CM) injection protocols adapted to tube voltage in patients undergoing Coronary Computed Tomography Angiography (CCTA). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Cardiovascular Diseases
- What is being tested?
- Ultravist 370Mg I/Ml Solution for Injection
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2017to 11 Feb 2019
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes 120 patients who present to radiology department for clinically indicated CCTA scan. In order to be included patients must meet all inclusion criteria and none of the exclusion criteria.
Who may be able to join
- Referred for a clinically indicated CCTA scan.
- Subject must be 18 - 85 years of age.
- Subject must provide written informed consent prior to any study-related procedures being performed.
- Subject must be willing to comply with all clinical study procedures.
Who cannot join
- Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
- By testing (serum or urine beta HCG) within 24 hours before study agent administration, or
- By surgical sterilization, or
- Post-menopausal, with minimum one (1) year history without menses.
- Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that is not 70, 80, 90, 100, 110, 120, or 130 kV.
- Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that has previously reached the maximum subject number (20 subjects per tube voltage).
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- Subject has an acute psychiatric disorder.
- Subject is unwilling to comply with the requirements of the protocol.
- Subject has previously entered this study.
- Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study.
- Subject has impaired renal function (creatinine > 1.5 mg/dl).
- Subject is in unstable condition.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography (VOLCANIC-CTA): A Prospective Trial
The purpose of this study is to prospectively evaluate the effectiveness of low-volume contrast media (CM) injection protocols adapted to tube voltage in patients undergoing Coronary Computed Tomography Angiography (CCTA).
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases
- Being tested
- Ultravist 370Mg I/Ml Solution for Injection
- Keywords
- Computed Tomography
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultravist 370Mg I/Ml Solution for InjectionDrug
Also called Iopromide
Reduced contrast-volume injection protocols based on patient specific tube voltage.
| Study group | Role | What they receive |
|---|---|---|
| Low-volume contrast media injection protocol | Patients will receive a low-volume contrast media (Ultravist 370Mg I/Ml Solution for Injection) injection protocol that is tailored to a specific tube voltage. Tube voltages will be automatically selected by the scanner to be used for the CCTA acquisition. Receives: Drug: Ultravist 370Mg I/Ml Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative assessment of image quality
This will be performed by two independent observers using a semi-quantitative rating scale of 1 - 5. Image quality will be graded on a five-point scoring system: 1 non-diagnostic; 2 limited diagnostic value; 3 adequate (presence of artifacts not limiting detection of luminal stenosis); 4 good; 5 excellent. Image quality assessments will be performed on both the investigative and control groups.
Measured: 2 years
Quantitative assessment of image quality
Measurements and calculations will be performed by two independent observers who will be blinded to image acquisition parameters. Signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) will be measured for all images.
Measured: 2 years
Secondary outcomes (1)
Radiation dose of coronary CTA
Determine the radiation dose (mSv) associated with low-volume contrast injection CCTA protocols.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start22 Mar 2017
- Primary completion11 Feb 2019
- Study completion11 Feb 2019
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179592
- Sponsor's protocol ID
- Pro00060805
- Acronym
- VOLCANIC-CTA
- Status last verified
- Feb 2020
- First submitted
- 1 Jun 2017
- Last updated
- 13 Feb 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography (VOLCANIC-CTA): A Prospective Trial
- ClinicalTrials.gov ID
- NCT03179592
- Acronym / sponsor ID
- VOLCANIC-CTA / Pro00060805
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases
- Keywords
- Computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 7 Jun 2017 (actual)
- 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.
The purpose of this study is to prospectively evaluate the effectiveness of low-volume contrast media (CM) injection protocols adapted to tube voltage in patients undergoing Coronary Computed Tomography Angiography (CCTA).
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-volume contrast media injection protocol | – | Drug: Ultravist 370Mg I/Ml Solution for InjectionPatients will receive a low-volume contrast media (Ultravist 370Mg I/Ml Solution for Injection) injection protocol that is tailored to a specific tube voltage. Tube voltages will be automatically selected by the scanner to be used for the CCTA acquisition. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes 120 patients who present to radiology department for clinically indicated CCTA scan. In order to be included patients must meet all inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (4 listed)
- Referred for a clinically indicated CCTA scan.
- Subject must be 18 - 85 years of age.
- Subject must provide written informed consent prior to any study-related procedures being performed.
- Subject must be willing to comply with all clinical study procedures.
Key exclusion criteria (12 listed)
- Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
- Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that is not 70, 80, 90, 100, 110, 120, or 130 kV.
- Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that has previously reached the maximum subject number (20 subjects per tube voltage).
- Subject has an acute psychiatric disorder.
- Subject is unwilling to comply with the requirements of the protocol.
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 |
|---|---|---|
| Ultravist 370Mg I/Ml Solution for InjectionAlso: IopromideReduced contrast-volume injection protocols based on patient specific tube voltage. | Drug | Low-volume contrast media injection protocol |
Primary outcome
Qualitative assessment of image quality
Time frame: 2 years
This will be performed by two independent observers using a semi-quantitative rating scale of 1 - 5. Image quality will be graded on a five-point scoring system: 1 non-diagnostic; 2 limited diagnostic value; 3 adequate (presence of artifacts not limiting detection of luminal stenosis); 4 good; 5 excellent. Image quality assessments will be performed on both the investigative and control groups.
Quantitative assessment of image quality
Time frame: 2 years
Measurements and calculations will be performed by two independent observers who will be blinded to image acquisition parameters. Signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) will be measured for all images.
1 secondary outcome
Radiation dose of coronary CTA
Time frame: 2 years
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 13 Feb 2020.
- Individual participant dataSharing planned: No
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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.
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?
An observational study of Coronary Artery Disease and Cardiovascular Diseases, run by Medical University of South Carolina 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 4 inclusion and 12 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 13 Feb 2020. 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?
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?
Qualitative assessment of image quality (time frame: 2 years). The study lists 2 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 13 Feb 2020.