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

NCT ID: NCT06733961

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-06-30

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.

Conditions

Pulmonary Embolism Acute

Keywords

SCUBE-1; VAP-1; Pulmonary Embolism

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient group

It consists of patients diagnosed with Pulmonary Thromboembolism who meet the inclusion and exclusion criteria.

SCUBE-1 and VAP-1

Intervention Type: DIAGNOSTIC_TEST

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

Control group

It was composed of healthy volunteers of similar age and gender who did not have any acute complaints.

SCUBE-1 and VAP-1

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

SCUBE-1 and VAP-1

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Giresun University

OTHER

Sponsor Role: lead

Responsible Party

İskender Aksoy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hizir U. Akdemir, Prof.

Role: STUDY_CHAIR

Ondokuz Mayıs University

Locations

Ondokuz Mayis University

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Dirican N, Duman A, Saglam G, Arslan A, Ozturk O, Atalay S, Bircan A, Akkaya A, Cakir M. The diagnostic significance of signal peptide-complement C1r/C1s, Uegf, and Bmp1-epidermal growth factor domain-containing protein-1 levels in pulmonary embolism. Ann Thorac Med. 2016 Oct-Dec;11(4):277-282. doi: 10.4103/1817-1737.191876.

Reference Type: BACKGROUND

PMID: 27803754 (View on PubMed)

Turkmen S, Sahin A, Gunaydin M, Sahin S, Mentese A, Turedi S, Karahan SC, Ozsu S, Gunduz A. The value of signal peptide-CUB-EGF domain-containing protein-1 (SCUBE1) in the diagnosis of pulmonary embolism: a preliminary study. Acad Emerg Med. 2015 Aug;22(8):922-6. doi: 10.1111/acem.12721. Epub 2015 Jul 22.

Reference Type: BACKGROUND

PMID: 26202675 (View on PubMed)

Other Identifiers

OMÜ KAEK 2019/26

Identifier Type: -

Identifier Source: org_study_id