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

Chongqing Emergency Medical Center

Status

Enrolling

Conditions

Contrast Media Adverse Reaction

Treatments

Drug: Iopamidol

Study type

Interventional

Funder types

Other

Identifiers

NCT05489055

ChongqingEMC

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.