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 (RIGHT)

October 1, 2018 updated by: Bayer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1214

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Multiple Locations, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.
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
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.
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
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.
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
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.
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
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.
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
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.
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
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.
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
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 1 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Value of CNR (contrast-noise ratio) of the vascular segments
Time Frame: Up to 1 week
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
Up to 1 week
Value of SNR (signal-noise ratio) of the vascular segments
Time Frame: Up to 1 week
Calculated by the formula: SNR = Averaged vascular segmental CT value / image noise
Up to 1 week
Score of visual assessment of the CTA image quality
Time Frame: Up to 1 week

Subjective visual assessment using a 4-point scale:

  1. Non-diagnostic
  2. Adequate
  3. Good
  4. Excellent
Up to 1 week
Score of diagnostic confidence of the CTA images
Time Frame: Up to 1 week

Subjective assessment of diagnostic confidence in the delineation of pathologic findings using a 4-point scale:

  1. Insufficient
  2. Adequate
  3. Good
  4. Excellent
Up to 1 week
Injected dosage (ml) of the contrast media (CM)
Time Frame: Up to 24 hours
Can be read from the screen of the CT injector.
Up to 24 hours
Injection rate (ml/s) of the contrast media
Time Frame: Up to 24 hours
Can be read from the screen of the CT injector.
Up to 24 hours
Value of the Idoine delivery rate (IDR) (unit: mg I/s)
Time Frame: Up to 1 week

Calculated by the formula:

IDR (mg I/s) = CM concentration (mg I/ml) * CM injection rate (ml/s)
Up to 1 week
Value of the volume CT dose index (CTDIvol) (unit: mGy)
Time Frame: Up to 1 week
A parameter of the radiation dose which can be automatically generated and recorded by the CT machine.
Up to 1 week
Value of the dose length product (DLP) (unit: mGy*cm)
Time Frame: Up to 1 week
A parameter of the radiation dose which can be automatically generated and recorded by the CT machine.
Up to 1 week
Value of the effective dose (organ dose) (unit: mSv)
Time Frame: Up to 1 week
The effective radiation dose which can be estimated by DLP multiplied by a specific conversion coefficient.
Up to 1 week
Heart rate of the patients who underwent CCTA before and after the CM injection
Time Frame: Up to 24 hours
It can be read from the screen of the ECG monitor of the CT machine
Up to 24 hours
Presence of injection pain or discomfort of the patients (Yes/No)
Time Frame: Up to 24 hours
Assessed by investigators by asking patients if they have injection pain or discomfort.
Up to 24 hours
Number of patients with adverse events / adverse drug reactions
Time Frame: Up to 1 hour
Up to 1 hour
Severity of injection pain or discomfort of the patients
Time Frame: Up to 24 hours
Assessed by investigators by asking the patients of the severity (mild, moderate, severe) if present.
Up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17811

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