Clinical trial NCT05489055: Effects of Contrast Media Temperature on Image Quality and Clinical Adverse Events in Coronary CTA
Official title: Department of Radiology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contrast Media Adverse Reaction
Keywords: Computed Tomography Angiography
Low-osmolality contrast media
Image quality
Clinical adverse event
Lead sponsor: Chongqing Emergency Medical Center
Sponsor class: OTHER
Collaborators: name: Army Medical Center of PLA
First posted: 2022-08-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Vessel Attenuation
timeFrame: Expected within one month after the coronary CTA is performed
Secondary outcomes:
measure: Allergic or allergiclike reaction
timeFrame: 30 minutes after coronary CTA
measure: Extravasations
timeFrame: Expected during the coronary CTA scan.
measure: Objective image quality - Signal-to-noise ratio(SNR)
timeFrame: Within one month after the CT is performed
measure: Objective image quality -Contrast-to-noise ratio(CNR)
timeFrame: Within one month after the CT is performed
measure: CT Dose Index (CTDI)vol
timeFrame: Expected during the coronary CTA is performed
measure: Physiologic reactions-Urgency desire
timeFrame: Immediately after CT
measure: Body Mass Index
timeFrame: Right before the scan is performed
measure: Subjective image quality
timeFrame: Within one month after the CT is performed
measure: Heart rate
timeFrame: During the coronary CTA.
measure: Flow rate
timeFrame: Within one month after the CT is performed
measure: Dose-length product (DLP)
timeFrame: Within one month after the CT is performed
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Emergency Mediacl Centre
state: Chonqing
Study officials:
References:
citation: 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.
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 1;57(2):85-89. doi: 10.1097/RLI.0000000000000807.