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

NCT ID: NCT06212882

Last Updated: 2024-01-19

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

RECRUITING

Total Enrollment

2100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lower concentration and lower volume contrast agent group

Lower concentration and lower volume contrast agent group

Intervention Type DIAGNOSTIC_TEST

CT images using lower concentration and lower volume contrast material

Lower concentration and normal volume contrast agent group

Lower concentration and lower volume contrast agent group

Intervention Type DIAGNOSTIC_TEST

CT images using lower concentration and lower volume contrast material

Normal concentration and normal volume contrast agent group

No interventions assigned to this group

Interventions

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Lower concentration and lower volume contrast agent group

CT images using lower concentration and lower volume contrast material

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuxi People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peihua Lu

Director of Scientific Research Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wuxi People's Hospital

Wuxi, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangming Fang, Doctor

Role: CONTACT

+86 15295557003

Facility Contacts

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Peihua Lu, MD

Role: primary

+86 13621500031

Other Identifiers

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KY23055

Identifier Type: -

Identifier Source: org_study_id

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