YEARS Score vs CTPA in Pulmonary Embolism

NCT06067308 | Completed DMC

• 1 other identifier: MSC 265
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Performance of CTPA DIAGNOSTIC_TEST

Exposure to CT scan and injection of IV contrast

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Faculty of medicine

Cairo, Giza Governorate, 222, Egypt

Location

Related Publications (1)

• 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.

  PMID: 15761580 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: October 4, 2023
• Study Start: October 16, 2022
• Primary Completion: May 16, 2023
• Study Completion: June 13, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-09

Locations

EG (1)