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

Completed

• Conditions: Angiography; Multidetector Computed Tomography
• Interventions: Drug: Iopromide (Ultravist, BAY86-4877)

• Registration Number: NCT02840903
• Lead Sponsor: Bayer

Brief 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.

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 Timeline

• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-21
• Study Start: 2016-07-26
• Primary Completion: 2017-07-28
• Study Completion: 2017-10-11
• Status Verified: 2018-09
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1214

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Setting 3 of Iopromide	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 7 of Iopromide	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 6 of Iopromide	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 8 of Iopromide	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
Setting 4 of Iopromide	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 1 of Iopromide	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	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 5 of Iopromide	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

Primary Outcome Measures

Name	Time	Method
Contrast opacification of the target vascular segments, measured in Hounsfield Units (HU)	Up to 1 week	Defined as the CT value which can be measured on the CTA images.

Secondary Outcome Measures

Name	Time	Method
Score of visual assessment of the CTA image quality	Up to 1 week	Subjective visual assessment using a 4-point scale: 1. Non-diagnostic; 2. Adequate; 3. Good; 4. Excellent
Injected dosage (ml) of the contrast media (CM)	Up to 24 hours	Can be read from the screen of the CT injector.
Value of SNR (signal-noise ratio) of the vascular segments	Up to 1 week	Calculated by the formula: SNR = Averaged vascular segmental CT value / image noise
Number of patients with adverse events / adverse drug reactions	Up to 1 hour
Severity of injection pain or discomfort of the patients	Up to 24 hours	Assessed by investigators by asking the patients of the severity (mild, moderate, severe) if present.
Value of CNR (contrast-noise ratio) of the vascular segments	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
Value of the effective dose (organ dose) (unit: mSv)	Up to 1 week	The effective radiation dose which can be estimated by DLP multiplied by a specific conversion coefficient.
Heart rate of the patients who underwent CCTA before and after the CM injection	Up to 24 hours	It can be read from the screen of the ECG monitor of the CT machine
Presence of injection pain or discomfort of the patients (Yes/No)	Up to 24 hours	Assessed by investigators by asking patients if they have injection pain or discomfort.
Injection rate (ml/s) of the contrast media	Up to 24 hours	Can be read from the screen of the CT injector.
Score of diagnostic confidence of the CTA images	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
Value of the Idoine delivery rate (IDR) (unit: mg I/s)	Up to 1 week	Calculated by the formula: IDR (mg I/s) = CM concentration (mg I/ml) \* CM injection rate (ml/s)
Value of the volume CT dose index (CTDIvol) (unit: mGy)	Up to 1 week	A parameter of the radiation dose which can be automatically generated and recorded by the CT machine.
Value of the dose length product (DLP) (unit: mGy*cm)	Up to 1 week	A parameter of the radiation dose which can be automatically generated and recorded by the CT machine.