Age Related D-dimer Evaluation for the Exclusion of a Left Atrium Thrombus in Patients With Atrial Fibrillation (ADDIT-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02802488
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
José Castro, Brugmann University Hospital

Brief Summary:

Patients with atrial fibrillation are at increased risk of thrombus formation in the left heart, especially in the auricula and the atrium. Their presence increases the risk of ischemic stroke, especially during cardioversion, performed either by drug or by external electric shock. The gold standard to exclude this thrombus and consider cardioversion is the transesophageal echocardiography.

D-dimers, products of the degradation of fibrin, have been studied several times to assess the presence of thrombi in the body, especially in pulmonary embolism. In cardiology and despite several studies on the matter, there is currently no blood D-dimers value allowing to detect the presence of a thrombus with a good predictive value. Correlating the D-dimer values with age, as has been done for some years in pulmonary embolism, would give the opportunity to create a simple, inexpensive and widely applicable tool to eliminate the presence of a thrombus in the left heart.

If the results are satisfactory, the investigators might consider not using transesophageal echocardiography as this examination is unpleasant for the patient and operator dependant, unlike a standard blood sampling.

This study aims to test the following hypothesis: D-dimers values superior or equal to ten times the patient's age is predictive of a thrombus.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Blood sampling Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Age Related D-dimer Evaluation for the Exclusion of a Left Atrium Thrombus in Patients With Atrial Fibrillation (ADDIT-AF)
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: D-dimers
This arm encompasses patients between 18 and 80 years old and diagnosed with atrial fibrillation.
Procedure: Blood sampling

A blood sampling will be performed in patients diagnosed with atrial fibrillation in order to test if having a D-dimers value superior or equal to the patient's age is predictive of a thrombus.

Thombus will be diagnosed according to the standard of care.

Primary Outcome Measures :
  1. D-dimers concentration [ Time Frame: first day of hospitalization ]
    Concentration of D-dimers in the blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with de novo or recent atrial fibrillation requiring cardioversion, either by drug, by an electric shock or an intervention.

Exclusion Criteria:

  • valvulopathy
  • infection
  • neoplasia
  • inflammatory disease
  • recent surgery
  • pregnancy
  • aorta aneurism
  • deep vein thrombosis
  • pulmonary embolism

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 identifier (NCT number): NCT02802488

Contact: Alexandre Almorad, MD

CHU Brugmann Recruiting
Brussels, Belgium, 1020
Contact: Alexandre Almorad, MD   
Sponsors and Collaborators
Brugmann University Hospital
Principal Investigator: José Castro, MD CHU Brugmann
Principal Investigator: Alexandre Almorad, MD CHU Brugmann

Responsible Party: José Castro, Head of clinic, Brugmann University Hospital Identifier: NCT02802488     History of Changes
Other Study ID Numbers: CHUB-ADDIT-AF
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by José Castro, Brugmann University Hospital:
Atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action