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

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ClinicalTrials.gov Identifier: NCT04251247
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmet Can Topcu, Dr. Lutfi Kirdar Kartal Training and Research Hospital

Brief 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.

Condition or disease Intervention/treatment
Aortic Dissection Pulmonary Embolism Diagnostic Test: D-dimer/fibrinogen ratio

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Study Type : Observational
Estimated Enrollment : 159 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Diagnostic Value of D-dimer/Fibrinogen Ratio in Patients With Acute Aortic Dissection
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

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)




Primary Outcome Measures :
  1. Acute aortic dissection [ Time Frame: 24 hours ]
    Diagnosis of acute aortic dissection confirmed by contrast enhanced computed tomography, magnetic resonance imaging, echocardiography or aortography



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults presenting to emergency department with chest pain.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251247


Contacts
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Contact: Avni Uygar Seyhan, M.D. 902164583000 ext 30202 uygarseyhan@gmail.com
Contact: Ahmet Can Topcu, M.D. 902164583000 ext 22105 ahmetcan1987@gmail.com

Locations
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Turkey
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital Recruiting
Istanbul, Turkey, 34668
Contact: Ahmet Bolukcu, M.D.    902165424444 ext 4524    ahmetbolukcu@gmail.com   
Kartal Dr. Lutfi Kirdar Training and Research Hospital Recruiting
Istanbul, Turkey, 34890
Contact: Avni Uygar Seyhan, M.D.    902164583000 ext 30202    uygarseyhan@gmail.com   
Contact: Ahmet Can Topcu, M.D.    902164583000 ext 22105    ahmetcan1987@gmail.com   
Sponsors and Collaborators
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Publications:
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Responsible Party: Ahmet Can Topcu, Director of Department of Cardiovascular Surgery, Dr. Lutfi Kirdar Kartal Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04251247    
Other Study ID Numbers: 2020/514/169/B
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Aneurysm, Dissecting
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Aneurysm
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants