NCT05489055

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

Department of Radiology

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Chongqing Emergency Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-01-01
• Completion: 2023-02-28
• First posted: 2022-08-05
• Last updated: 2022-08-05

Locations

1 site across 1 country: China