Age Related D-dimer Evaluation for the Exclusion of a Left Atrium Thrombus in Patients With Atrial Fibrillation (ADDIT-AF)
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|ClinicalTrials.gov Identifier: NCT02802488|
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : January 23, 2018
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)|
|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|
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.
- D-dimers concentration [ Time Frame: first day of hospitalization ]Concentration of D-dimers in the blood
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): NCT02802488
|Contact: Alexandre Almorad, MD||Alexandre.ALMORAD@chu-brugmann.be|
|Brussels, Belgium, 1020|
|Contact: Alexandre Almorad, MD Alexandre.Almorad@chu-brugmann.be|
|Principal Investigator:||José Castro, MD||CHU Brugmann|
|Principal Investigator:||Alexandre Almorad, MD||CHU Brugmann|