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

NCT05489055 | Unknown DMC

• 1 other identifier: ChongqingEMC
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Contrast Media Adverse Reaction

Keywords

Computed Tomography Angiography; Low-osmolality contrast media; Image quality; Clinical adverse event

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Allergic or allergiclike reaction

  30 minutes after coronary CTA

• Extravasations

  Expected during the coronary CTA scan.

• Objective image quality - Signal-to-noise ratio(SNR)

  Within one month after the CT is performed

• Objective image quality -Contrast-to-noise ratio(CNR)

  Within one month after the CT is performed

• CT Dose Index (CTDI)vol

  Expected during the coronary CTA is performed

Study Arms (2)

BBT-CM (basic body temperature) group

EXPERIMENTAL

BBT-CM (basic body temperature) group received contrast media warmed to body temperature (37°C\[99°F\]) before coronary CTA.

Drug: Iopamidol

RT-CM (room temperature) group

ACTIVE COMPARATOR

RT-CM (room temperature) group received contrast media at room temperature (\~23°C \[\~73°F\]) before coronary CTA.

Drug: Iopamidol

Interventions

Iopamidol DRUG

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.

BBT-CM (basic body temperature) group; RT-CM (room temperature) group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coronary symptomatic patients (i.e., chest pain).
• Patients for Coronary artery disease screening

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chongqing Emergency Medical Center: lead
• Army Medical Center of PLA: collaborator

Study Sites (1)

Chongqing Emergency Mediacl Centre

Chongqing, Chonqing, 400042, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 34319163 BACKGROUND

• 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.

  PMID: 34280944 RESULT

• Peng C, Liu Y, Zhang H, Xu G, He C, Jian D, Liu H, Li C, Zeng P, Wu H. Effects of extrinsically warmed contrast media on image quality and clinical adverse events in patients undergoing coronary computed tomography angiography: a randomized controlled trial. Quant Imaging Med Surg. 2026 Jan 1;16(1):13. doi: 10.21037/qims-2025-121. Epub 2025 Dec 31.

  PMID: 41521999 DERIVED

MeSH Terms

Interventions

Iopamidol

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 5, 2022
• Study Start: February 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: February 28, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)