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)

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: Completed
• Conditions: Multidetector Computed Tomography; Angiography
• Intervention / Treatment: Drug: Iopromide (Ultravist, BAY86-4877)

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: Observational
• Enrollment (Actual): 1214

Contacts and Locations

Study Locations

• China
  • Multiple Locations, China

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Up to 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	Up to 1 week
Injected dosage (ml) of the contrast media (CM)	Can be read from the screen of the CT injector.	Up to 24 hours
Injection rate (ml/s) of the contrast media	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)	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)	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)	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)	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	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)	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		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.	Up to 24 hours

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General 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.

Helpful Links

• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2016
• Primary Completion (Actual): July 28, 2017
• Study Completion (Actual): October 11, 2017

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: CTA; Computed Tomographic Angiography
• Other Study ID Numbers: 17811