Pulmonary Embolism Clinical Trial
Official title:
Dual-Energy CT Angiography in Suspected Pulmonary Embolism: Influence of Concentration of Contrast Materials on Image Quality and Diagnostic Performance
NCT number | NCT06212882 |
Other study ID # | KY23055 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2023 |
Est. completion date | June 2025 |
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.
Status | Recruiting |
Enrollment | 2100 |
Est. completion date | June 2025 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Wuxi People's Hospital | Wuxi | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Wuxi People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | image quality evaluation of the CTPA images of 30% participants | the mean CT number (in Hounsfield units) in the main pulmonary artery by using a region of interest of at least 1 square centimeter.
the CT number (in Hounsfield units) of peripheral pulmonary arteries close to the beginning and the end of each scan in a egmental or subsegmental artery at an apical and a basal section position. Because the caliber of the peripheral vessels was too small to reliably set an intraluminal region of interest to determine the mean CT number, the maximum CT number as a proxy for vascular attenuation should be chosen. the images quality score for making a diagnosis other than PE ( using a five-point scale ranging from 1 to 5). |
through the CTPA examinations of 30% participants finished,, an average of six month | |
Secondary | overall diagnostic performance for pulmonary embolism | diagnostic accuracy, sensitivity and specificity | CTPA examinations all participants are finished, an average of two month |
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