Diagnostic Value of D-dimer/Fibrinogen Ratio in Patients With Acute Aortic Dissection

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 Overview

• Status: Recruiting
• Conditions: Pulmonary Embolism; Aortic Dissection
• Intervention / Treatment: Diagnostic test: D-dimer/fibrinogen ratio

• Study Type: Observational
• Enrollment (Estimated): 159

Contacts and Locations

• Study Contact: Name: Avni Uygar Seyhan, M.D.; Phone Number: 30202 902164583000; Email: uygarseyhan@gmail.com
• Study Contact Backup: Name: Ahmet Can Topcu, M.D.; Phone Number: 22105 902164583000; Email: ahmetcan1987@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34668
    • Recruiting
    • Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
    • Contact: Ahmet Bolukcu, M.D.; Phone Number: 4524 902165424444; Email: ahmetbolukcu@gmail.com
  • Istanbul, Turkey, 34890
    • Recruiting
    • Kartal Dr. Lutfi Kirdar Training and Research Hospital
    • Contact: Avni Uygar Seyhan, M.D.; Phone Number: 30202 902164583000; Email: uygarseyhan@gmail.com
    • Contact: Ahmet Can Topcu, M.D.; Phone Number: 22105 902164583000; Email: ahmetcan1987@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults presenting to emergency department with chest pain.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute aortic dissection; Patients with a diagnosis of acute aortic dissection.	Diagnostic test: D-dimer/fibrinogen ratio; The ratio of D-dimer (ng/ml) to fibrinogen (mg/dl)
Acute pulmonary embolism; Patients with a diagnosis of acute pulmonary embolism	Diagnostic test: D-dimer/fibrinogen ratio; The ratio of D-dimer (ng/ml) to fibrinogen (mg/dl)
Non-cardiac chest pain; Patients with non-cardiac chest pain	Diagnostic test: D-dimer/fibrinogen ratio; The ratio of D-dimer (ng/ml) to fibrinogen (mg/dl)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute aortic dissection	Diagnosis of acute aortic dissection confirmed by contrast enhanced computed tomography, magnetic resonance imaging, echocardiography or aortography	24 hours

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Embolism; Pulmonary Embolism; Aortic Dissection; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Fibrin fragment D
• Other Study ID Numbers: 2020/514/169/B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No