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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04251247
Other study ID # 2020/514/169/B
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date January 31, 2025

Study information

Verified date March 2024
Source Dr. Lutfi Kirdar Kartal Training and Research Hospital
Contact Avni Uygar Seyhan, M.D.
Phone 902164583000
Email uygarseyhan@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 159
Est. completion date January 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of acute aortic dissection - Diagnosis of acute pulmonary embolism - Diagnosis of non-cardiac chest pain Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
D-dimer/fibrinogen ratio
The ratio of D-dimer (ng/ml) to fibrinogen (mg/dl)

Locations

Country Name City State
Turkey Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital Istanbul
Turkey Kartal Dr. Lutfi Kirdar Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Eggebrecht 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. — View Citation

Guan 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. — View Citation

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. — View Citation

Kara 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Acute aortic dissection Diagnosis of acute aortic dissection confirmed by contrast enhanced computed tomography, magnetic resonance imaging, echocardiography or aortography 24 hours
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