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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Blood sampling

• Registration Number: NCT02802488
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-13
• Study First Posted: 2016-06-16
• Study Start: 2016-07-01
• Primary Completion: 2020-05-14
• Study Completion: 2020-05-14
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
D-dimers	Blood sampling	This arm encompasses patients between 18 and 80 years old and diagnosed with atrial fibrillation.

Primary Outcome Measures

Name	Time	Method
D-dimers concentration	first day of hospitalization	Concentration of D-dimers in the blood

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium