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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Contrast Media Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Iopamidol

Intervention Type 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.

RT-CM (room temperature) group

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

Group Type ACTIVE_COMPARATOR

Iopamidol

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No