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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02802488
• Other study ID #: CHUB-ADDIT-AF
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: May 14, 2020

Study information

• Verified date: July 2022
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: May 14, 2020
• Est. primary completion date: May 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	D-dimers concentration	Concentration of D-dimers in the blood	first day of hospitalization