Effects of Contrast Media Temperature on Image Quality and Clinical Adverse Events in Coronary CTA

Contrast Media Adverse Reaction Clinical Trial

Official title:

Department of Radiology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05489055
• Other study ID #: ChongqingEMC
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: August 2022
• Source: Chongqing Emergency Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 28, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contrast Media Adverse Reaction

Intervention

Drug:
• Iopamidol
A contrast bolus of iopamidol-370 (370 mg I/ml) (iopamidol injection; Consun Pharmaceutical, China) was injected at a ?ow 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.

Locations

Country	Name	City	State
China	Chongqing Emergency Mediacl Centre	Chongqing	Chonqing

Sponsors (2)

Lead Sponsor	Collaborator
Chongqing Emergency Medical Center	Army Medical Center of PLA

Country where clinical trial is conducted

China, 

References & Publications (2)

Basharat NF, Ranganathan K, Kang PT, Gridley DG, Roh AT. Effect of Extrinsic Warming of Low-Osmolality CT Contrast Media (Iohexol 350) on Extravasations and Patient Reaction Rates: A Retrospective Study. AJR Am J Roentgenol. 2022 Jan;218(1):174-179. doi: 10.2214/AJR.21.26256. Epub 2021 Jul 28. — View Citation

Martens B, Wildberger JE, Van Kuijk SMJ, De Vos-Geelen J, Jeukens CRLPN, Mihl C. Influence of Contrast Material Temperature on Patient Comfort and Image Quality in Computed Tomography of the Abdomen: A Randomized Controlled Trial. Invest Radiol. 2022 Feb — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vessel Attenuation	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.	Expected within one month after the coronary CTA is performed
Secondary	Allergic or allergiclike reaction	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.	30 minutes after coronary CTA
Secondary	Extravasations	The radiology staff recorded an estimate of the volume of extravasated contrast media	Expected during the coronary CTA scan.
Secondary	Objective image quality - Signal-to-noise ratio(SNR)	mean attenuation of vessel divided by the mean SD	Within one month after the CT is performed
Secondary	Objective image quality -Contrast-to-noise ratio(CNR)	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	Within one month after the CT is performed
Secondary	CT Dose Index (CTDI)vol	CTDIvol (in mGy) the patient received	Expected during the coronary CTA is performed
Secondary	Physiologic reactions-Urgency desire	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.	Immediately after CT
Secondary	Body Mass Index	The formula is BMI = kg/m2 , where kg is a person's weight in kilograms and m2 is their height in metres squared.	Right before the scan is performed
Secondary	Subjective image quality	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).	Within one month after the CT is performed
Secondary	Heart rate	Heart rate (beats per minute) is monitor during the coronary CTA.	During the coronary CTA.
Secondary	Flow rate	Flow rate of the contrast media in ml/s.	Within one month after the CT is performed
Secondary	Dose-length product (DLP)	DLP (in mGycm) the patient received	Within one month after the CT is performed