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

Department of Radiology

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.

Study Overview

• Status: Recruiting
• Conditions: Contrast Media Adverse Reaction
• Intervention / Treatment: Drug: Iopamidol

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chonqing
    • Chongqing, Chonqing, China, 400042
      • Recruiting
      • Chongqing Emergency Mediacl Centre
      • Contact: Chao Peng, MD; Phone Number: +82-23-63692257; Email: 523945695@qq.com
      • Principal Investigator: Hao Wu, Ph.D
      • Sub-Investigator: Ping Zeng, MD&Ph.D
      • Sub-Investigator: Chuangming Li, MD&Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BBT-CM (basic body temperature) group; BBT-CM (basic body temperature) group received contrast media warmed to body temperature (37°C[99°F]) before coronary CTA.	Drug: Iopamidol; 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.
Active Comparator: RT-CM (room temperature) group; RT-CM (room temperature) group received contrast media at room temperature (~23°C [~73°F]) before coronary CTA.	Drug: Iopamidol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Extravasations	The radiology staff recorded an estimate of the volume of extravasated contrast media	Expected during the coronary CTA scan.
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
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
CT Dose Index (CTDI)vol	CTDIvol (in mGy) the patient received	Expected during the coronary CTA is performed
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
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
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
Heart rate	Heart rate (beats per minute) is monitor during the coronary CTA.	During the coronary CTA.
Flow rate	Flow rate of the contrast media in ml/s.	Within one month after the CT is performed
Dose-length product (DLP)	DLP (in mGycm) the patient received	Within one month after the CT is performed

Collaborators and Investigators

• Sponsor: Chongqing Emergency Medical Center
• Collaborators: Army Medical Center of PLA

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Image quality; Computed Tomography Angiography; Low-osmolality contrast media; Clinical adverse event
• Other Study ID Numbers: ChongqingEMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No