Clinical trial NCT06067308: YEARS Score vs CTPA in Pulmonary Embolism
Official title: Predictive Accuracy of YEARS Score in Diagnosis of Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators' aim in this study is to assess the sensitivity and accuracy of YEARS algorithm in the diagnosis of PE.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Any patient more than 18 years old presenting to the emergency room with symptoms of clinically suspected pulmonary embolism such as:

  * Sudden onset of dyspnea, sudden deterioration of existing dyspnea, sudden onset of pleuritic chest pain without another apparent cause.
  * Any other symptoms like hemoptysis, syncope or unilateral leg pain.

Exclusion Criteria:

* Pregnancy

  * Allergy to intra-venous contrast agents
  * Renal insufficiency (creatinine clearance \< 30 mL/min).

Primary outcomes:
measure: YEARS score vs CTPA in diagnosis of PE
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine
state: Giza
Study officials:
References:
citation: Almeida NA, de Sousa JT, Bachion MM, Silveira Nde A. [The use of respiration and relaxation techniques for pain and anxiety relief in the parturition process]. Rev Lat Am Enfermagem. 2005 Jan-Feb;13(1):52-8. doi: 10.1590/s0104-11692005000100009. Epub 2005 Mar 3. Portuguese.