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

Angiography Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840903
• Other study ID #: 17811
• Status: Completed
• Start date: July 26, 2016
• Est. completion date: October 11, 2017

Study information

• Verified date: September 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1214
• Est. completion date: October 11, 2017
• Est. primary completion date: July 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angiography
• Multidetector Computed Tomography

Intervention

Drug:
• Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Injected dosage (ml) of the contrast media (CM)	Can be read from the screen of the CT injector.	Up to 24 hours
Secondary	Injection rate (ml/s) of the contrast media	Can be read from the screen of the CT injector.	Up to 24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of patients with adverse events / adverse drug reactions		Up to 1 hour
Secondary	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

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