Aortic DissectionNCT04251247
Diagnostic Value of D-dimer/Fibrinogen Ratio in Patients With Acute Aortic Dissection
An observational study of Aortic Dissection and Pulmonary Embolism, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Acute aortic dissection is rare but potentially life-threatening disease with an incidence of 5-30 cases per million, annually. Therefore prompt diagnosis is crucial. D-dimer values have been shown to be useful in the diagnosis of acute aortic dissection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection, Pulmonary Embolism
- What is being tested?
- D-dimer/fibrinogen ratio
- How many people
- 159 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 31 Jan 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults presenting to emergency department with chest pain.
Who may be able to join
- Diagnosis of acute aortic dissection
- Diagnosis of acute pulmonary embolism
- Diagnosis of non-cardiac chest pain
Who cannot join
- Any etiology of chest pain other than acute aortic dissection, acute pulmonary embolism, or non-cardiac chest pain
- Participants who do not give consent for enrollment
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul, 34668
Ahmet Bolukcu, M.D., 902165424444 ext. 4524, ahmetbolukcu@gmail.com
- Recruiting
Kartal Dr. Lutfi Kirdar Training and Research Hospital
Istanbul, 34890
Avni Uygar Seyhan, M.D., 902164583000 ext. 30202, uygarseyhan@gmail.com
Ahmet Can Topcu, M.D., 902164583000 ext. 22105, ahmetcan1987@gmail.com
About this study
Acute aortic dissection is rare but potentially life-threatening disease with an incidence of 5-30 cases per million, annually. Therefore prompt diagnosis is crucial. D-dimer values have been shown to be useful in the diagnosis of acute aortic dissection. Fibrinogen levels have been shown to be low, normal or high in individuals with acute aortic dissection. This study aims to investigate whether D-dimer/fibrinogen ratio can be valuable for diagnosis of acute aortic dissection.
- Conditions
- Aortic Dissection, Pulmonary Embolism
- Being tested
- D-dimer/fibrinogen ratio
- Medical subject headings
- Aortic Dissection, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-dimer/fibrinogen ratioDiagnostic test
The ratio of D-dimer (ng/ml) to fibrinogen (mg/dl)
| Study group | Role | What they receive |
|---|---|---|
| Acute aortic dissection | Patients with a diagnosis of acute aortic dissection. Receives: Diagnostic Test: D-dimer/fibrinogen ratio | |
| Acute pulmonary embolism | Patients with a diagnosis of acute pulmonary embolism Receives: Diagnostic Test: D-dimer/fibrinogen ratio | |
| Non-cardiac chest pain | Patients with non-cardiac chest pain Receives: Diagnostic Test: D-dimer/fibrinogen ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute aortic dissection
Diagnosis of acute aortic dissection confirmed by contrast enhanced computed tomography, magnetic resonance imaging, echocardiography or aortography
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start1 Mar 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic DissectionStudies 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
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmet Can Topcu, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251247
- Sponsor's protocol ID
- 2020/514/169/B
- Status last verified
- Mar 2024
- First submitted
- 30 Jan 2020
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hajsadeghi S, Kerman SR, Khojandi M, Vaferi H, Ramezani R, Jourshari NM, Mousavi SA, Pouraliakbar H. Accuracy of D-dimer:fibrinogen ratio to diagnose pulmonary thromboembolism in patients admitted to intensive care units. Cardiovasc J Afr. 2012 Sep;23(8):446-56. doi: 10.5830/CVJA-2012-041.
PubMed 23044500Kara H, Bayir A, Degirmenci S, Kayis SA, Akinci M, Ak A, Celik B, Dogru A, Ozturk B. D-dimer and D-dimer/fibrinogen ratio in predicting pulmonary embolism in patients evaluated in a hospital emergency department. Acta Clin Belg. 2014 Aug;69(4):240-5. doi: 10.1179/2295333714Y.0000000029.
PubMed 25012747Guan XL, Wang XL, Liu YY, Lan F, Gong M, Li HY, Liu O, Jiang WJ, Liu YM, Zhu JM, Sun LZ, Zhang HJ. Changes in the Hemostatic System of Patients With Acute Aortic Dissection Undergoing Aortic Arch Surgery. Ann Thorac Surg. 2016 Mar;101(3):945-51. doi: 10.1016/j.athoracsur.2015.08.047. Epub 2015 Oct 23.
PubMed 26603023Eggebrecht H, Naber CK, Bruch C, Kroger K, von Birgelen C, Schmermund A, Wichert M, Bartel T, Mann K, Erbel R. Value of plasma fibrin D-dimers for detection of acute aortic dissection. J Am Coll Cardiol. 2004 Aug 18;44(4):804-9. doi: 10.1016/j.jacc.2004.04.053.
PubMed 15312863
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of D-dimer/Fibrinogen Ratio in Patients With Acute Aortic Dissection
- ClinicalTrials.gov ID
- NCT04251247
- Acronym / sponsor ID
- 2020/514/169/B
- Conditions
- Aortic Dissection, Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 31 Jan 2020 (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 aortic dissection is rare but potentially life-threatening disease with an incidence of 5-30 cases per million, annually. Therefore prompt diagnosis is crucial. D-dimer values have been shown to be useful in the diagnosis of acute aortic dissection. Fibrinogen levels have been shown to be low, normal or high in individuals with acute aortic dissection. This study aims to investigate whether D-dimer/fibrinogen ratio can be valuable for diagnosis of acute aortic dissection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute aortic dissection | – | Diagnostic Test: D-dimer/fibrinogen ratioPatients with a diagnosis of acute aortic dissection. |
| Acute pulmonary embolism | – | Diagnostic Test: D-dimer/fibrinogen ratioPatients with a diagnosis of acute pulmonary embolism |
| Non-cardiac chest pain | – | Diagnostic Test: D-dimer/fibrinogen ratioPatients with non-cardiac chest pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults presenting to emergency department with chest pain.
Key inclusion criteria (3 listed)
- Diagnosis of acute aortic dissection
- Diagnosis of acute pulmonary embolism
- Diagnosis of non-cardiac chest pain
Key exclusion criteria (2 listed)
- Any etiology of chest pain other than acute aortic dissection, acute pulmonary embolism, or non-cardiac chest pain
- Participants who do not give consent for enrollment
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 |
|---|---|---|
| D-dimer/fibrinogen ratioThe ratio of D-dimer (ng/ml) to fibrinogen (mg/dl) | Diagnostic test | Acute aortic dissection, Acute pulmonary embolism, Non-cardiac chest pain |
Primary outcome
Acute aortic dissection
Time frame: 24 hours
Diagnosis of acute aortic dissection confirmed by contrast enhanced computed tomography, magnetic resonance imaging, echocardiography or aortography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 23044500Hajsadeghi S, Kerman SR, Khojandi M, Vaferi H, Ramezani R, Jourshari NM, Mousavi SA, Pouraliakbar H. Accuracy of D-dimer:fibrinogen ratio to diagnose pulmonary thromboembolism in patients admitted to intensive care units. Cardiovasc J Afr. 2012 Sep;23(8):446-56. doi: 10.5830/CVJA-2012-041.
- Background: PubMed 25012747Kara H, Bayir A, Degirmenci S, Kayis SA, Akinci M, Ak A, Celik B, Dogru A, Ozturk B. D-dimer and D-dimer/fibrinogen ratio in predicting pulmonary embolism in patients evaluated in a hospital emergency department. Acta Clin Belg. 2014 Aug;69(4):240-5. doi: 10.1179/2295333714Y.0000000029.
- Background: PubMed 26603023Guan XL, Wang XL, Liu YY, Lan F, Gong M, Li HY, Liu O, Jiang WJ, Liu YM, Zhu JM, Sun LZ, Zhang HJ. Changes in the Hemostatic System of Patients With Acute Aortic Dissection Undergoing Aortic Arch Surgery. Ann Thorac Surg. 2016 Mar;101(3):945-51. doi: 10.1016/j.athoracsur.2015.08.047. Epub 2015 Oct 23.
- Background: PubMed 15312863Eggebrecht H, Naber CK, Bruch C, Kroger K, von Birgelen C, Schmermund A, Wichert M, Bartel T, Mann K, Erbel R. Value of plasma fibrin D-dimers for detection of acute aortic dissection. J Am Coll Cardiol. 2004 Aug 18;44(4):804-9. doi: 10.1016/j.jacc.2004.04.053.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection and Pulmonary Embolism, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Avni Uygar Seyhan, M.D. (902164583000 ext. 30202, uygarseyhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute aortic dissection (time frame: 24 hours). 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 NCT04251247, which also lists 4 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 15 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.