AngiographyRIGHTNCT02840903
A Non-interventional Study to Observe the Computed Tomographic Angiography Image Quality With Different Contrast Media Injection Protocols Under Different Computed Tomography Machines Parameters Setting
An observational study of Angiography and Multidetector Computed Tomography, run by Bayer at 1 site in China.
Trial summary
The objective of this study is to evaluate the image quality for different iodine delivery rates at different low voltage scanning protocols (80 or 100 kV ) under the modern advanced Multi-Detector Computed Tomography (MDCT) considering the body weight of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angiography, Multidetector Computed Tomography
- What is being tested?
- Iopromide (Ultravist, BAY86-4877)
- Type of treatment
- Injection or infusion
- How many people
- 1,214 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2016to 11 Oct 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for CT Angiography for examination of the cerebral arteries (suspicion of cerebral artery stenosis or embolism, or suspected carotid pathology) or for examination of the coronary arteries receiving Ultravist at 80 or 100 kV can be enrolled in this study.
Who may be able to join
- Patients for whom the decision to initiate CTA will be made as per investigator's routine practice.
- Adult patients (age ≥18 years) with a weight ≤ 90 kg.
- Written Informed Consent.
Who cannot join
- A history of hypersensitivity to iodinated contrast agents.
- Known or suspected hyperthyroidism or pheochromocytoma.
- Atrial fibrillation or any other cardiac arrhythmia that would preclude reliable ECG gating; have severe congestive heart failure (New York Heart Classification IV).
- Pregnant or lactating women.
- Patients participating in another clinical study.
- Patients who underwent PCI (percutaneous coronary intervention) or CABG (coronary artery bypass grafting) before the index CTA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Image Quality in Coronary or Craniocervical CT Angiography With Different Iodine Delivery Rates Using Low Tube Voltage (80 or 100 kV) Imaging in MDCT
The objective of this study is to evaluate the image quality for different iodine delivery rates at different low voltage scanning protocols (80 or 100 kV ) under the modern advanced Multi-Detector Computed Tomography (MDCT) considering the body weight of patients.
Read the detailed description
The purpose of this study is to evaluate the image quality of different acquisition protocols in patients weighing less than 90 kg using low voltage 80 or 100 kV with a lower Iodine Delivery Rate based on the body weight of the patient, who will undertake coronary or craniocervical CTA (Computed Tomography Angiography) in routine procedures.
- Conditions
- Angiography, Multidetector Computed Tomography
- Being tested
- Iopromide (Ultravist, BAY86-4877)
- Keywords
- CTA, Computed Tomographic Angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iopromide (Ultravist, BAY86-4877)Drug
8 settings for CT Angiography as described in group description.
| Study group | Role | What they receive |
|---|---|---|
| Setting 1 of Iopromide | Craniocervical CTA under below setting: injection rate of iopromide: 4 ml/s, concentration of iopromide = 300 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 80 kvp Receives: Drug: Iopromide (Ultravist, BAY86-4877) | |
| Setting 2 of Iopromide | Craniocervical CTA under below setting: injection rate of iopromide: 3.2 ml/s, concentration of iopromide = 370 mgI/ml, injection dose of iopromide: 0.65 ml/kg BW, tube voltage = 80 kvp Receives: Drug: Iopromide (Ultravist, BAY86-4877) | |
| Setting 3 of Iopromide | Craniocervical CTA under below setting: injection rate of iopromide: 3.2 ml/s, concentration of iopromide = 300 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 80 kvp Receives: Drug: Iopromide (Ultravist, BAY86-4877) | |
| Setting 4 of Iopromide | Craniocervical CTA under below setting: injection rate of iopromide: 4 ml/s, concentration of iopromide = 370 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 100 kvp Receives: Drug: Iopromide (Ultravist, BAY86-4877) | |
| Setting 5 of Iopromide | Coronary CTA under below setting: injection rate of iopromide: 4 ml/s, concentration of iopromide = 300 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 80 kvp Receives: Drug: Iopromide (Ultravist, BAY86-4877) | |
| Setting 6 of Iopromide | Coronary CTA under below setting: injection rate of iopromide: 3.2 ml/s, concentration of iopromide = 370 mgI/ml, injection dose of iopromide: 0.65 ml/kg BW, tube voltage = 80 kvp Receives: Drug: Iopromide (Ultravist, BAY86-4877) | |
| Setting 7 of Iopromide | Coronary CTA under below setting: injection rate of iopromide: 3.2 ml/s, concentration of iopromide = 300 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 80 kvp Receives: Drug: Iopromide (Ultravist, BAY86-4877) | |
| Setting 8 of Iopromide | Coronary CTA under below setting: injection rate of iopromide: 4 ml/s, concentration of iopromide = 370 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 100 kvp Receives: Drug: Iopromide (Ultravist, BAY86-4877) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast opacification of the target vascular segments, measured in Hounsfield Units (HU)
Defined as the CT value which can be measured on the CTA images.
Measured: Up to 1 week
Secondary outcomes (14)
Value of CNR (contrast-noise ratio) of the vascular segments
Calculated by the formula: CNR = [Averaged vascular segmental CT value - brain parenchyma (for carniocervical CTA) / perivascular tissues (for Coronary CTA (CCTA)) CT value] / image noise
Measured: Up to 1 week
Value of SNR (signal-noise ratio) of the vascular segments
Calculated by the formula: SNR = Averaged vascular segmental CT value / image noise
Measured: Up to 1 week
Score of visual assessment of the CTA image quality
Subjective visual assessment using a 4-point scale:
- Non-diagnostic
- Adequate
- Good
- Excellent
Measured: Up to 1 week
Score of diagnostic confidence of the CTA images
Subjective assessment of diagnostic confidence in the delineation of pathologic findings using a 4-point scale:
- Insufficient
- Adequate
- Good
- Excellent
Measured: Up to 1 week
Injected dosage (ml) of the contrast media (CM)
Can be read from the screen of the CT injector.
Measured: Up to 24 hours
Injection rate (ml/s) of the contrast media
Can be read from the screen of the CT injector.
Measured: Up to 24 hours
Value of the Idoine delivery rate (IDR) (unit: mg I/s)
Calculated by the formula:
IDR (mg I/s) = CM concentration (mg I/ml) * CM injection rate (ml/s)
Measured: Up to 1 week
Value of the volume CT dose index (CTDIvol) (unit: mGy)
A parameter of the radiation dose which can be automatically generated and recorded by the CT machine.
Measured: Up to 1 week
Value of the dose length product (DLP) (unit: mGy*cm)
A parameter of the radiation dose which can be automatically generated and recorded by the CT machine.
Measured: Up to 1 week
Value of the effective dose (organ dose) (unit: mSv)
The effective radiation dose which can be estimated by DLP multiplied by a specific conversion coefficient.
Measured: Up to 1 week
Heart rate of the patients who underwent CCTA before and after the CM injection
It can be read from the screen of the ECG monitor of the CT machine
Measured: Up to 24 hours
Presence of injection pain or discomfort of the patients (Yes/No)
Assessed by investigators by asking patients if they have injection pain or discomfort.
Measured: Up to 24 hours
Number of patients with adverse events / adverse drug reactions
Measured: Up to 1 hour
Severity of injection pain or discomfort of the patients
Assessed by investigators by asking the patients of the severity (mild, moderate, severe) if present.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start26 Jul 2016
- Primary completion28 Jul 2017
- Study completion11 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AngiographyStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840903
- Sponsor's protocol ID
- 17811
- Acronym
- RIGHT
- Status last verified
- Sep 2018
- First submitted
- 6 Jul 2016
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang Y, Chen Y, Liu P, Lv W, Wu J, Wei M, Shi D, Wu X, Liu W, Tao X, Hu H, Ma X, Yang X, Xue H, Jin Z. Clinical effectiveness of contrast medium injection protocols for 80-kV coronary and craniocervical CT angiography-a prospective multicenter observational study. Eur Radiol. 2022 Jun;32(6):3808-3818. doi: 10.1007/s00330-021-08505-5. Epub 2022 Feb 1.
PubMed 35103828
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Image Quality in Coronary or Craniocervical CT Angiography With Different Iodine Delivery Rates Using Low Tube Voltage (80 or 100 kV) Imaging in MDCT
- ClinicalTrials.gov ID
- NCT02840903
- Acronym / sponsor ID
- RIGHT / 17811
- Conditions
- Angiography, Multidetector Computed Tomography
- Keywords
- CTA, Computed Tomographic Angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,214 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2016 (actual)
- Primary completion
- 28 Jul 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 21 Jul 2016 (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.
The objective of this study is to evaluate the image quality for different iodine delivery rates at different low voltage scanning protocols (80 or 100 kV ) under the modern advanced Multi-Detector Computed Tomography (MDCT) considering the body weight of patients.
Detailed description
The purpose of this study is to evaluate the image quality of different acquisition protocols in patients weighing less than 90 kg using low voltage 80 or 100 kV with a lower Iodine Delivery Rate based on the body weight of the patient, who will undertake coronary or craniocervical CTA (Computed Tomography Angiography) in routine procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Setting 1 of Iopromide | – | Drug: Iopromide (Ultravist, BAY86-4877)Craniocervical CTA under below setting: injection rate of iopromide: 4 ml/s, concentration of iopromide = 300 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 80 kvp |
| Setting 2 of Iopromide | – | Drug: Iopromide (Ultravist, BAY86-4877)Craniocervical CTA under below setting: injection rate of iopromide: 3.2 ml/s, concentration of iopromide = 370 mgI/ml, injection dose of iopromide: 0.65 ml/kg BW, tube voltage = 80 kvp |
| Setting 3 of Iopromide | – | Drug: Iopromide (Ultravist, BAY86-4877)Craniocervical CTA under below setting: injection rate of iopromide: 3.2 ml/s, concentration of iopromide = 300 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 80 kvp |
| Setting 4 of Iopromide | – | Drug: Iopromide (Ultravist, BAY86-4877)Craniocervical CTA under below setting: injection rate of iopromide: 4 ml/s, concentration of iopromide = 370 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 100 kvp |
| Setting 5 of Iopromide | – | Drug: Iopromide (Ultravist, BAY86-4877)Coronary CTA under below setting: injection rate of iopromide: 4 ml/s, concentration of iopromide = 300 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 80 kvp |
| Setting 6 of Iopromide | – | Drug: Iopromide (Ultravist, BAY86-4877)Coronary CTA under below setting: injection rate of iopromide: 3.2 ml/s, concentration of iopromide = 370 mgI/ml, injection dose of iopromide: 0.65 ml/kg BW, tube voltage = 80 kvp |
| Setting 7 of Iopromide | – | Drug: Iopromide (Ultravist, BAY86-4877)Coronary CTA under below setting: injection rate of iopromide: 3.2 ml/s, concentration of iopromide = 300 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 80 kvp |
| Setting 8 of Iopromide | – | Drug: Iopromide (Ultravist, BAY86-4877)Coronary CTA under below setting: injection rate of iopromide: 4 ml/s, concentration of iopromide = 370 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 100 kvp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for CT Angiography for examination of the cerebral arteries (suspicion of cerebral artery stenosis or embolism, or suspected carotid pathology) or for examination of the coronary arteries receiving Ultravist at 80 or 100 kV can be enrolled in this study.
Key inclusion criteria (3 listed)
- Patients for whom the decision to initiate CTA will be made as per investigator's routine practice.
- Adult patients (age ≥18 years) with a weight ≤ 90 kg.
- Written Informed Consent.
Key exclusion criteria (6 listed)
- A history of hypersensitivity to iodinated contrast agents.
- Known or suspected hyperthyroidism or pheochromocytoma.
- Atrial fibrillation or any other cardiac arrhythmia that would preclude reliable ECG gating; have severe congestive heart failure (New York Heart Classification IV).
- Pregnant or lactating women.
- Patients participating in another clinical study.
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 |
|---|---|---|
| Iopromide (Ultravist, BAY86-4877)8 settings for CT Angiography as described in group description. | Drug | Setting 1 of Iopromide, Setting 2 of Iopromide, Setting 3 of Iopromide, Setting 4 of Iopromide, Setting 5 of Iopromide, Setting 6 of Iopromide, Setting 7 of Iopromide, Setting 8 of Iopromide |
Primary outcome
Contrast opacification of the target vascular segments, measured in Hounsfield Units (HU)
Time frame: Up to 1 week
Defined as the CT value which can be measured on the CTA images.
14 secondary outcomes
Value of CNR (contrast-noise ratio) of the vascular segments
Time frame: Up to 1 week
Value of SNR (signal-noise ratio) of the vascular segments
Time frame: Up to 1 week
Score of visual assessment of the CTA image quality
Time frame: Up to 1 week
Score of diagnostic confidence of the CTA images
Time frame: Up to 1 week
Injected dosage (ml) of the contrast media (CM)
Time frame: Up to 24 hours
Injection rate (ml/s) of the contrast media
Time frame: Up to 24 hours
Value of the Idoine delivery rate (IDR) (unit: mg I/s)
Time frame: Up to 1 week
Value of the volume CT dose index (CTDIvol) (unit: mGy)
Time frame: Up to 1 week
Value of the dose length product (DLP) (unit: mGy*cm)
Time frame: Up to 1 week
Value of the effective dose (organ dose) (unit: mSv)
Time frame: Up to 1 week
Heart rate of the patients who underwent CCTA before and after the CM injection
Time frame: Up to 24 hours
Presence of injection pain or discomfort of the patients (Yes/No)
Time frame: Up to 24 hours
Number of patients with adverse events / adverse drug reactions
Time frame: Up to 1 hour
Severity of injection pain or discomfort of the patients
Time frame: Up to 24 hours
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 2 Oct 2018.
- Derived from this study: PubMed 35103828Wang Y, Chen Y, Liu P, Lv W, Wu J, Wei M, Shi D, Wu X, Liu W, Tao X, Hu H, Ma X, Yang X, Xue H, Jin Z. Clinical effectiveness of contrast medium injection protocols for 80-kV coronary and craniocervical CT angiography-a prospective multicenter observational study. Eur Radiol. 2022 Jun;32(6):3808-3818. doi: 10.1007/s00330-021-08505-5. Epub 2022 Feb 1.
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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.
Bayer Study Director study director
Bayer
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 Angiography and Multidetector Computed Tomography, run by Bayer at 1 site in China.
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 3 inclusion and 6 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 2 Oct 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 China. 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?
Contrast opacification of the target vascular segments, measured in Hounsfield Units (HU) (time frame: Up to 1 week). 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 NCT02840903, 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 2 Oct 2018.