Pulmonary Embolism AcuteNCT06733961
SCUBE-1 and VAP-1 Levels on Diagnosis Pulmonary Embolism
An observational study of Pulmonary Embolism Acute, run by Giresun University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism Acute
- What is being tested?
- SCUBE-1 and VAP-1
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 30 Jun 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- being older than 18 years of age
- presenting to the emergency department,
- diagnosed with acute PTE by contrast-enhanced computed tomography angiography
Who cannot join
- having acute ischemic disease, liver, kidney or advanced heart failure, liver disease, pregnancy, active malignancy or hematological disease, and a known history of PTE.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- SCUBE-1 and VAP-1
- Keywords
- SCUBE-1, VAP-1, Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCUBE-1 and VAP-1Diagnostic test
There is no other study comparing these biomarkers with healthy volunteers in the diagnosis of pulmonary embolism.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | It consists of patients diagnosed with Pulmonary Thromboembolism who meet the inclusion and exclusion criteria. Receives: 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. Receives: Diagnostic Test: SCUBE-1 and VAP-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Secondary outcomes (2)
Difference between clinical probability scores and serum SCUBE-1 and VAP-1 levels.
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.
Measured: 6 month
difference between early mortality risk and serum SCUBE-1 and VAP-1 levels.
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start1 Jan 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Embolism AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İskender Aksoy, Giresun University
- Investigators
- Hizir U. Akdemir, Prof., Study chair, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733961
- Sponsor's protocol ID
- OMÜ KAEK 2019/26
- Status last verified
- Nov 2024
- First submitted
- 1 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27803754Turkmen 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.
PubMed 26202675
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06733961
- Acronym / sponsor ID
- OMÜ KAEK 2019/26
- Conditions
- Pulmonary Embolism Acute
- Keywords
- SCUBE-1, VAP-1, Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Diagnostic Test: SCUBE-1 and VAP-1It consists of patients diagnosed with Pulmonary Thromboembolism who meet the inclusion and exclusion criteria. |
| Control group | – | Diagnostic Test: SCUBE-1 and VAP-1It was composed of healthy volunteers of similar age and gender who did not have any acute complaints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- being older than 18 years of age
- presenting to the emergency department,
- diagnosed with acute PTE by contrast-enhanced computed tomography angiography
Key exclusion criteria (1 listed)
- having acute ischemic disease, liver, kidney or advanced heart failure, liver disease, pregnancy, active malignancy or hematological disease, and a known history of PTE.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCUBE-1 and VAP-1There is no other study comparing these biomarkers with healthy volunteers in the diagnosis of pulmonary embolism. | Diagnostic test | Control group, Patient group |
Primary outcome
Diagnostic ability of SCUBE-1 and VAP-1 in pulmonary embolism
Time frame: 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.
2 secondary outcomes
Difference between clinical probability scores and serum SCUBE-1 and VAP-1 levels.
Time frame: 6 month
difference between early mortality risk and serum SCUBE-1 and VAP-1 levels.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Results publication: PubMed 27803754Dirican 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.
- Results publication: PubMed 26202675Turkmen 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.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Embolism Acute
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
Not yet recruitingPhase 3
Reduced-Dose Thrombolysis in Intermediate-Risk Pulmonary Embolism With High-Risk Features
Pulmonary Embolism
Not yet recruiting
Percutaneous Mechanical Thrombectomy With or Without Low-Dose Catheter-Directed Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism
Acute Pulmonary Embolism
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hizir U. Akdemir, Prof. study chair
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism Acute, run by Giresun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic ability of SCUBE-1 and VAP-1 in pulmonary embolism (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06733961, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.