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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02840903
Other study ID # 17811
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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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