Faculty of medicine
Cairo, Giza Governorate, 222, Egypt
NCT Number: NCT06067308
The investigators' aim in this study is to assess the sensitivity and accuracy of YEARS algorithm in the diagnosis of PE.
Looking for future studies?
Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Cairo, Giza Governorate, 222, Egypt
Pulmonary embolism (PE) is a relatively common acute cardiovascular disorder with high early mortality rates that, despite advances in diagnosis and treatment over the past 30 years, have not changed significantly. Due to pulmonary bed obstruction, PE can result in acute right ventricular (RV) failure. Because most patients ultimately die within the first hours of presentation, early diagnosis is of paramount importance.
The incidence of PE is estimated to be approximately 60 to 70 per 100,000, and that of venous thrombosis approximately 124 per 100,000 of the general population.
Because of its diagnostic accuracy and wide availability, multidetector row computed tomography pulmonary angiography (CTPA) is the imaging test of choice to confirm acute pulmonary embolism in most patients. Increasing use of CTPA with diminishing prevalence of pulmonary embolism to even less than 10% has led to overdiagnosis of mostly subsegmental pulmonary embolism and unnecessary risks of radiation exposure and contrast medium induced nephropathy.
To avoid these problems, validated diagnostic algorithms for suspected acute pulmonary embolism, using sequential testing, have been introduced. In these algorithms, a normal D-dimer test result in patients with low probability safely excludes pulmonary embolism.
YEARS scoring system is an algorithm to predict diagnosis of pulmonary embolism according to clinical signs and D-dimer. The aim of this study is to test predictive accuracy, sensitivity and specificity of YEARS score compared to CTPA in the diagnosis of PE as CTPA is an invasive procedure, expensive and not readily available in many settings, thus, finding an alternative easier method that can diagnose PE may help save the time and resources.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exposure to CT scan and injection of IV contrast
Time frame: One year
In patients with no YEARS items and a D-dimer concentration less than 1000 ng/mL, pulmonary embolism was considered excluded and further testing was withheld. In patients with one or more YEARS items and a D-dimer concentration less than 500 ng/mL, pulmonary embolism was also considered excluded and further testing was withheld. All other patients i.e., either with no YEARS item and a D-dimer concentration of 1000 ng/mL or more, or with one or more items and a concentration of 500 ng/mL or more were referred for CTPA to show or exclude the diagnosis of pulmonary embolism.
Kasr El Aini Hospital
Other
Predictive Accuracy of YEARS Score in Diagnosis of Pulmonary Embolism
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06015529
Cardiovascular Diseases, Embolism
Brussels, Belgium
View Trial DetailsNCT04014972
Acute Aortic Syndrome, Aneurysm
View Trial DetailsNCT07689136
Cardiovascular Diseases, Deep Vein Thrombosis
Tunis, Tunisia
View Trial DetailsNCT06183944
Cardiovascular Diseases, Embolism
Toulon, France
View Trial Details