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Contrast Media Adverse ReactionNCT05489055

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

A study testing Iopamidol in people with Contrast Media Adverse Reaction, run by Chongqing Emergency Medical Center at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Contrast Media Adverse Reaction
What is being tested?
Iopamidol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteChina
Study dates
1 Feb 2022to 28 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Chongqing Emergency Mediacl Centre

    Chongqing, Chonqing, 400042

    Chao Peng, MD, +82-23-63692257, 523945695@qq.com

    Hao Wu, Ph.D

    Recruiting

Other trials in China

About this study

Official title: Department of Radiology

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.

Being tested
Iopamidol
Keywords
Computed Tomography Angiography, Low-osmolality contrast media, Image quality, Clinical adverse event

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IopamidolDrug

    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.

Study groups in NCT05489055
Study groupRoleWhat they receive
BBT-CM (basic body temperature) groupExperimentalBBT-CM (basic body temperature) group received contrast media warmed to body temperature (37°C[99°F]) before coronary CTA.
Receives: Drug: Iopamidol
RT-CM (room temperature) groupActive comparatorRT-CM (room temperature) group received contrast media at room temperature (~23°C [~73°F]) before coronary CTA.
Receives: Drug: Iopamidol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Expected within one month after the coronary CTA is performed

Secondary outcomes (11)

  1. Allergic or allergiclike reaction

    Allergic and allergic-like reactions were identified by evaluating notes within the EMR for elements of such reactions specified in nomenclature from the ACR manual. Allergic reactions were recorded according to symptoms of an immune response to the CM, such as feeling cold urticaria or pruritis.

    Measured: 30 minutes after coronary CTA

  2. Extravasations

    The radiology staff recorded an estimate of the volume of extravasated contrast media

    Measured: Expected during the coronary CTA scan.

  3. Objective image quality - Signal-to-noise ratio(SNR)

    mean attenuation of vessel divided by the mean SD

    Measured: Within one month after the CT is performed

  4. Objective image quality -Contrast-to-noise ratio(CNR)

    mean vascular attenuation minus HU of the vessel, divided by the SD of the attenuation of epicardial fat surrounding left main coronary artery and then divided by image noise

    Measured: Within one month after the CT is performed

  5. CT Dose Index (CTDI)vol

    CTDIvol (in mGy) the patient received

    Measured: Expected during the coronary CTA is performed

  6. Physiologic reactions-Urgency desire

    Urgency desire is defined in the questionnaire as the sudden and intense ''urge'' or need to urinate and scored 1=Not at all, 2=A little, 3= Moderately, 4=A great deal, and 5=A very great deal.

    Measured: Immediately after CT

  7. Body Mass Index

    The formula is BMI = kg/m2 , where kg is a person's weight in kilograms and m2 is their height in metres squared.

    Measured: Right before the scan is performed

  8. Subjective image quality

    Rated in consensus on a 5-point Likert scale by two radiologists: 1=excellent (absence of artifacts related to motion or coronary calcification); 2=good (minor artifacts); 3=moderate (considerable artifacts but maintained visualization of the arterial lumen); and 4=poor (non-diagnostic because of severe motion artifacts or severe coronary calcification).

    Measured: Within one month after the CT is performed

  9. Heart rate

    Heart rate (beats per minute) is monitor during the coronary CTA.

    Measured: During the coronary CTA.

  10. Flow rate

    Flow rate of the contrast media in ml/s.

    Measured: Within one month after the CT is performed

  11. Dose-length product (DLP)

    DLP (in mGycm) the patient received

    Measured: Within one month after the CT is performed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study start1 Feb 2022
  3. Primary completion1 Jan 2023 (estimated)
  4. Study completion28 Feb 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05489055
Sponsor's protocol ID
ChongqingEMC
Status last verified
Aug 2022
First submitted
1 Aug 2022
Last updated
5 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34319163

  • 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.

    PubMed 34280944

  • 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.

    PubMed 41521999

Questions about this trial

What is this clinical trial studying?

A study testing Iopamidol in people with Contrast Media Adverse Reaction, run by Chongqing Emergency Medical Center at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vessel Attenuation (time frame: Expected within one month after the coronary CTA is performed). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05489055, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.

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