SCUBE-1 and VAP-1 Levels on Diagnosis Pulmonary Embolism

Completed

• Conditions: Pulmonary Embolism Acute

• Registration Number: NCT06733961
• Lead Sponsor: Giresun University

Brief Summary

Acute pulmonary thromboembolism is a life-threatening disease. Clinical suspicion is essential for diagnosis because of lack of a specific finding for diagnosis of PTE. The aim of this study is to investigate the relationship between the diagnosis and prognosis of alternative biomarkers such as SCUBE-1 and VAP-1 in the diagnosis of clinically suspected acute PTE.

Patients who were admitted to the Emergency Department and diagnosed as acute PTE were included in the study. Patients with acute ischemic disease, liver failure, renal failure, pregnancy, active malignancy and/or history of known PTE were excluded from the study. A control group was formed from healthy volunteers at similar age and sex. SCUBE-1 and VAP-1 levels were studied from serum samples taken from the patient and control groups. Data were analyzed using by IBM SPSS V23.

Detailed Description

The definitive diagnosis of APT is made by ventilation/perfusion (V/Q) scintigraphy and thorax computed tomography angiography (CTA). There is no specific examination as a laboratory parameter. A definitive diagnosis cannot be made with d-Dimer, which is the most frequently used laboratory test today; it is used to exclude the diagnosis of APT.

The non-specificity of the clinical picture, the fact that the diagnosis depends on the experience of the physician and the necessity of exposure to radiation and contrast material for the definitive diagnosis has revealed the necessity of searching for alternative ways for the diagnosis of APT. "Signal peptide CUB-EGF domain-containing protein-1" (SCUBE-1) is a biomarker released during platelet aggregation, and "Vascular adhesion protein-1" (VAP-1) is a biomarker released from endothelium, and these biomarkers show promise for the diagnosis of APT.

Determination of serum SCUBE-1 and serum VAP-1 levels 5 mL blood taken from the peripheral veins of the patients was placed in a biochemistry tube and centrifuged at 3000 g. After centrifugation, the serum part of the blood was separated and taken into an eppendorf tube and stored in an ultra-deep freezer at minus 80°C until the study day. Before starting the study, the ELISA kits kept at 2-8°C and the samples kept in an ultra-deep freezer at minus 80°C were brought to room temperature.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2024-11
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• being older than 18 years of age
• presenting to the emergency department,
• diagnosed with acute PTE by contrast-enhanced computed tomography angiography

Exclusion Criteria

• having acute ischemic disease, liver, kidney or advanced heart failure, liver disease, pregnancy, active malignancy or hematological disease, and a known history of PTE.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic ability of SCUBE-1 and VAP-1 in pulmonary embolism	6 month	Serum SCUBE-1 and serum VAP-1 levels of the Patient and Control groups will be measured in serum mg/dL with 5 mL of blood taken from the peripheral veins.

Secondary Outcome Measures

Name	Time	Method
Difference between clinical probability scores and serum SCUBE-1 and VAP-1 levels.	6 month	The clinical probability scores of the patient group will be grouped as 'low, medium, high' and 'APT likely, APT unlikely'. Serum SCUBE-1 and serum VAP-1 levels measured in the patient group will be measured in the subgroups of clinical probability scores.
difference between early mortality risk and serum SCUBE-1 and VAP-1 levels.	28 days	For the patient group, 'low, medium-low, medium-high, high' risk groups will be determined for the 28-day early mortality risk. Serum SCUBE-1 and serum VAP-1 levels will be measured for these subgroups.

Trial Locations

Locations (1)

Ondokuz Mayis University; 🇹🇷 Samsun, Turkey