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

Investigation of the Relationship of SCUBE-1 and VAP-1 Levels on Diagnosis, Prognosis and Clinical Results in Patients with Pulmonary Thromboembolism Diagnosis in Emergency Department

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06733961
Enrollment
88
Registered
2024-12-13
Start date
2019-01-01
Completion date
2019-06-30
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism Acute

Keywords

SCUBE-1, VAP-1, Pulmonary Embolism

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.

Interventions

DIAGNOSTIC_TESTSCUBE-1 and VAP-1

There is no other study comparing these biomarkers with healthy volunteers in the diagnosis of pulmonary embolism.

Sponsors

Giresun University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic ability of SCUBE-1 and VAP-1 in pulmonary embolism6 monthSerum 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

MeasureTime frameDescription
Difference between clinical probability scores and serum SCUBE-1 and VAP-1 levels.6 monthThe 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 daysFor 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026