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Optimization of DE-CTPA Images and Diagnostic Pathway: Using Low Concentration Iodine Contrast Material

W

Wuxi People's Hospital

Status

Enrolling

Conditions

Pulmonary Embolism

Treatments

Diagnostic Test: Lower concentration and lower volume contrast agent group

Study type

Observational

Funder types

Other

Identifiers

NCT06212882
KY23055

Details and patient eligibility

About

The investigators aimed to compare the image quality and diagnostic performance of DECTPA using lower concentration iodine contrast materials and using normal concentration iodine contrast materials in the evaluation of suspected pulmonary embolism.

Full description

All patients met the inclusion and exclusion criteria will be given written informed consensus. The enrolled patients will randomly receive one of the three injection protocols: A: 30mL Iomeprol (Iomeron 300, Bracco Imaging, Milano, Italia) injected at a flow rate of 4mL/s; B: 50mL Iomeprol (Iomeron 300, Bracco Imaging, Milano, Italia) injected at a flow rate of 4mL/s; C: 50mL Ioversol (Ioversol 350, Hengrui, Jiansun, China) injected at a flow rate of 4mL/s. A and B groups are both lower concentration iodine contrast material groups, with different total iodine loads.

Enrollment

2,100 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age greater than 18 years old
  • Clinical suspicion of pulmonary embolism suggests CTPA examination (Wells score>4 or D-2 polymer elevation)
  • Patient's general physical condition tolerates CTPA examination

Exclusion criteria

  • Allergy to iodine contrast agents
  • Hyperthyroidism
  • Pregnancy
  • Weight greater than 80kg
  • Heart failure patients, NYHA heart function level III or IV

Trial design

2,100 participants in 3 patient groups

Lower concentration and lower volume contrast agent group
Treatment:
Diagnostic Test: Lower concentration and lower volume contrast agent group
Lower concentration and normal volume contrast agent group
Treatment:
Diagnostic Test: Lower concentration and lower volume contrast agent group
Normal concentration and normal volume contrast agent group

Trial contacts and locations

1

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Central trial contact

Xiangming Fang, Doctor

Data sourced from clinicaltrials.gov

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