Angiography, Multidetector Computed Tomography
Conditions
Keywords
CTA, Computed Tomographic Angiography
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.
Interventions
8 settings for CT Angiography as described in group description.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Injected dosage (ml) of the contrast media (CM) | Up to 24 hours | Can be read from the screen of the CT injector. |
| Injection rate (ml/s) of the contrast media | Up to 24 hours | Can be read from the screen of the CT injector. |
| 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 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 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. |
| 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. |
| 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 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. |
Countries
China
Outcome results
None listed