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YEARS Score vs CTPA in Pulmonary Embolism

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Performance of CTPA
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Embolism

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Faculty of medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

to assess the sensitivity and accuracy of YEARS score in the diagnosis of PE.

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2023
Last Updated
September 28, 2023
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06067308
Brief Title
YEARS Score vs CTPA in Pulmonary Embolism
Official Title
Predictive Accuracy of YEARS Score in Diagnosis of Pulmonary Embolism
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 16, 2022 (Actual)
Primary Completion Date
May 16, 2023 (Actual)
Study Completion Date
June 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
to assess the sensitivity and accuracy of YEARS score in the diagnosis of PE.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Performance of CTPA
Intervention Description
Exposure to CT scan and injection of IV contrast
Primary Outcome Measure Information:
Title
YEARS score vs CTPA in diagnosis of PE
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Faculty of medicine
City
Cairo
State/Province
Giza
ZIP/Postal Code
222
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
15761580
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.
Results Reference
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YEARS Score vs CTPA in Pulmonary Embolism

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