YEARS Score vs CTPA in Pulmonary Embolism

Sponsor

Kasr El Aini Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06067308

Collaborator

(none)

Enrollment

Location

Arm

7.9

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism	Diagnostic Test: Performance of CTPA	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Predictive Accuracy of YEARS Score in Diagnosis of Pulmonary Embolism

Actual Study Start Date :

Oct 16, 2022

Actual Primary Completion Date :

May 16, 2023

Actual Study Completion Date :

Jun 13, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

YEARS score vs CTPA in diagnosis of PE [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine	Cairo	Giza	Egypt	222

Sponsors and Collaborators

Kasr El Aini Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Hussien Fayiad, Clinical Professor, Kasr El Aini Hospital

ClinicalTrials.gov Identifier:

NCT06067308

Other Study ID Numbers:

MSC 265

First Posted:

Oct 4, 2023

Last Update Posted:

Oct 4, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pulmonary Embolism

Embolism

Study Results

No Results Posted as of Oct 4, 2023