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

NCT06212882 | Unknown DMC

• 1 other identifier: KY23055
• Study Type: observational
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Embolism

Keywords

pulmonary embolism; Computed Tomography; contrast materials

Outcome Measures

Primary Outcomes (1)

• image quality evaluation of the CTPA images of 30% participants

  1. the mean CT number (in Hounsfield units) in the main pulmonary artery by using a region of interest of at least 1 square centimeter. 2. 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. 3. 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 Outcomes (1)

• overall diagnostic performance for pulmonary embolism

  CTPA examinations all participants are finished, an average of two month

Study Arms (3)

Lower concentration and lower volume contrast agent group

Diagnostic Test: Lower concentration and lower volume contrast agent group

Lower concentration and normal volume contrast agent group

Diagnostic Test: Lower concentration and lower volume contrast agent group

Normal concentration and normal volume contrast agent group

Interventions

Lower concentration and lower volume contrast agent group DIAGNOSTIC_TEST

CT images using lower concentration and lower volume contrast material

Lower concentration and lower volume contrast agent group; Lower concentration and normal volume contrast agent group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients who will undergo CT pulmonary angiography due to clinical suspicion of pulmonary embolism

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wuxi People's Hospital: lead

Study Sites (1)

Wuxi People's Hospital

Wuxi, Jiangsu, 214043, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xiangming Fang, Doctor

CONTACT

+86 15295557003; mengxp0711@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Scientific Research Department

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 19, 2024
• Study Start: September 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: June 1, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the main paper is published.
• Access Criteria: application from the Central Contact Person

Locations

CN (1)