Contrast Media Adverse Reaction
Conditions
Keywords
Computed Tomography Angiography, Low-osmolality contrast media, Image quality, Clinical adverse event
Brief summary
Extrinsic prewarming of iodinated CT contrast media (CM) to body temperature reduces viscosity and injection pressures. However, guideline recommendations on the necessity to prewarm iodinated CM are conflicting. And studies examining the effect of extrinsic warming CM for coronary CTA(CCTA) on clinical adverse events and image quality are lack. Enrolled patients of chest pain or coronary artery disease screening were eligible for this a double-blinded, randomized noninferiority trial, and equally allocated into two group randomly: BBT-CM (basic body temperature) group received 37°C CM; RT-CM (room temperature) group received \ 23°C CM. A state-of-the-art individualized CM (iopamidol at 370 mg I/mL) injection protocol was used, based on body weight.
Interventions
DRUGIopamidol
A contrast bolus of iopamidol-370 (370 mg I/ml) (iopamidol injection; Consun Pharmaceutical, China) was injected at a flow rate of 4.5-6 mL/s through an 18-20-gauge intravenous antecubital catheter by using a power injector (Ulrich, Germany). The total dose of iopamidol-370 was approximately 0.9 ml /kg body weight.
Sponsors
Army Medical Center of PLA
Chongqing Emergency Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Coronary symptomatic patients (i.e., chest pain). * Patients for Coronary artery disease screening
Exclusion criteria
* Hemodynamic instability * Renal insufficiency (estimated glomerular filtration rate \<30 mL/min per 1.73 m2) * Prior adverse reactions to iodinated CM * Age younger than 18 years * Inability to place an 18-gauge needle.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vessel Attenuation | Expected within one month after the coronary CTA is performed | Mean attenuation in Hounsfield Units (HU) is based on coronary bifurcation, preferably right coronary artery (RCA), left anterior descending artery (LAD), and left circumflex coronary artery (LCX)). Absolute difference in mean attenuation of coronary vessels between groups was calculated with a two-sided 95% confidence interval of the difference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extravasations | Expected during the coronary CTA scan. | The radiology staff recorded an estimate of the volume of extravasated contrast media |
| Objective image quality - Signal-to-noise ratio(SNR) | Within one month after the CT is performed | mean attenuation of vessel divided by the mean SD |
| Objective image quality -Contrast-to-noise ratio(CNR) | Within one month after the CT is performed | mean vascular attenuation minus HU of the vessel, divided by the SD of the attenuation of epicardial fat surrounding left main coronary artery and then divided by image noise |
| CT Dose Index (CTDI)vol | Expected during the coronary CTA is performed | CTDIvol (in mGy) the patient received |
| Physiologic reactions-Urgency desire | Immediately after CT | Urgency desire is defined in the questionnaire as the sudden and intense ''urge'' or need to urinate and scored 1=Not at all, 2=A little, 3= Moderately, 4=A great deal, and 5=A very great deal. |
| Allergic or allergiclike reaction | 30 minutes after coronary CTA | Allergic and allergic-like reactions were identified by evaluating notes within the EMR for elements of such reactions specified in nomenclature from the ACR manual. Allergic reactions were recorded according to symptoms of an immune response to the CM, such as feeling cold urticaria or pruritis. |
| Subjective image quality | Within one month after the CT is performed | Rated in consensus on a 5-point Likert scale by two radiologists: 1=excellent (absence of artifacts related to motion or coronary calcification); 2=good (minor artifacts); 3=moderate (considerable artifacts but maintained visualization of the arterial lumen); and 4=poor (non-diagnostic because of severe motion artifacts or severe coronary calcification). |
| Heart rate | During the coronary CTA. | Heart rate (beats per minute) is monitor during the coronary CTA. |
| Flow rate | Within one month after the CT is performed | Flow rate of the contrast media in ml/s. |
| Dose-length product (DLP) | Within one month after the CT is performed | DLP (in mGycm) the patient received |
| Body Mass Index | Right before the scan is performed | The formula is BMI = kg/m2 , where kg is a person's weight in kilograms and m2 is their height in metres squared. |
Countries
China
Outcome results
None listed