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

NCT06733961 | Completed

• 1 other identifier: OMÜ KAEK 2019/26
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism Acute

Keywords

SCUBE-1; VAP-1; Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• Diagnostic ability of SCUBE-1 and VAP-1 in pulmonary embolism

  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.

  6 month

Secondary Outcomes (2)

• Difference between clinical probability scores and serum SCUBE-1 and VAP-1 levels.

  6 month

• difference between early mortality risk and serum SCUBE-1 and VAP-1 levels.

  28 days

Study Arms (2)

Patient group

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

Diagnostic Test: SCUBE-1 and VAP-1

Control group

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

Diagnostic Test: SCUBE-1 and VAP-1

Interventions

SCUBE-1 and VAP-1 DIAGNOSTIC_TEST

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

Control group; Patient group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who applied to the emergency department of Samsun Ondokuz Mayis Universtiy between 01.01.2019 and 30.06.2019 and were diagnosed with acute pulmonary thromboembolism (APT) by contrast-enhanced thorax computed tomography were included in the study. A group of healthy volunteers with similar gender, age and exclusion criteria was formed with the patients with APT included in the study. Demographic data, clinical probability scores (Wells' criteria, revised Geneva score), simplified Pulmonary Embolism Severity Index (sPESI) and early mortality risk score (in 30 days) of the patients were recorded.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, 55200, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 27803754 BACKGROUND

• 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.

  PMID: 26202675 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

To study SCUBE-1 and VAP-1, 5 cc of blood was taken from each patient and healthy volunteer.

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

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

Study Officials

• Hizir U. Akdemir, Prof.

  Ondokuz Mayıs University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 13, 2024
• Study Start: January 1, 2019
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: December 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)