YEARS Score vs CTPA in Pulmonary Embolism

Predictive Accuracy of YEARS Score in Diagnosis of Pulmonary Embolism

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Diagnostic test: Performance of CTPA

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 222
      • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: to assess the sensitivity and accuracy of YEARS score in the diagnosis of PE.; 50 patients with suspected PE were evaluated in Chest Department at faculty of medicine, Kasr Al-Ainy Hospital. At the beginning, clinical evaluation using YEARS score was done; subsequently for definitive diagnosis, computed tomography pulmonary angiography was performed in all cases as a reference method.

Diagnostic test: Performance of CTPA; Exposure to CT scan and injection of IV contrast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
YEARS score vs CTPA in diagnosis of PE	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.	One year

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2022
• Primary Completion (Actual): May 16, 2023
• Study Completion (Actual): June 13, 2023

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: MSC 265

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No