Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date January 2024
Source Wuxi People's Hospital
Contact Xiangming Fang, Doctor
Phone +86 15295557003
Email mengxp0711@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Lower concentration and lower volume contrast agent group
CT images using lower concentration and lower volume contrast material

Locations

Country Name City State
China Wuxi People's Hospital Wuxi Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Wuxi People's Hospital

Country where clinical trial is conducted

China, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05050617 - Point-of-Care Ultrasound in Predicting Adverse Outcomes in Emergency Department Patients With Acute Pulmonary Embolism
Terminated NCT04558125 - Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism Phase 4
Not yet recruiting NCT06017271 - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Completed NCT03915925 - Short-term Clinical Deterioration After Acute Pulmonary Embolism
Completed NCT02502396 - Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
Recruiting NCT05171075 - A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE Phase 3
Completed NCT04454554 - Prevalence of Pulmonary Embolism in Patients With Dyspnea on Exertion (PEDIS)
Completed NCT03173066 - Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography Phase 1
Terminated NCT03002467 - Impact Analysis of Prognostic Stratification for Pulmonary Embolism N/A
Completed NCT02334007 - Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery Phase 1/Phase 2
Completed NCT02611115 - Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography. N/A
Completed NCT01975090 - The SENTRY Clinical Study N/A
Not yet recruiting NCT01357941 - Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE) N/A
Completed NCT01326507 - Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism N/A
Completed NCT00720915 - D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months N/A
Completed NCT00773448 - Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism N/A
Completed NCT00780767 - Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism Phase 2
Completed NCT02476526 - Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease Phase 4
Completed NCT00771303 - Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
Completed NCT00816920 - Natural History of Isolated Deep Vein Thrombosis of the Calf