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

Department of Radiology

Sponsors

Lead Sponsor: Chongqing Emergency Medical Center

Collaborator: Army Medical Center of PLA

Source Chongqing Emergency Medical Center
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.

Overall Status Recruiting
Start Date 2022-02-01
Completion Date 2023-02-28
Primary Completion Date 2023-01-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Vessel Attenuation Expected within one month after the coronary CTA is performed
Secondary Outcome
Measure Time Frame
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
Physiologic reactions-Urgency desire Immediately after CT
Body Mass Index Right before the scan is performed
Subjective image quality Within one month after the CT is performed
Heart rate During the coronary CTA.
Flow rate Within one month after the CT is performed
Dose-length product (DLP) Within one month after the CT is performed
Enrollment 500
Condition
Intervention

Intervention Type: Drug

Intervention Name: Iopamidol

Description: 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.

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

90 Years

Healthy Volunteers:

No

Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Status: Contact: Investigator: Chongqing Emergency Mediacl Centre Chao Peng, MD +82-23-63692257 [email protected] Hao Wu, Ph.D Principal Investigator Ping Zeng, MD&Ph.D Sub-Investigator Chuangming Li, MD&Ph.D Sub-Investigator
Location Countries

China

Verification Date

2022-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Chongqing Emergency Medical Center

Investigator Full Name: Hao Wu

Investigator Title: Associate professor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: BBT-CM (basic body temperature) group

Type: Experimental

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

Label: RT-CM (room temperature) group

Type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contrast Media Adverse Reaction

Clinical Trials on Iopamidol