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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02802488
Enrollment
142
Registered
2016-06-16
Start date
2016-07-01
Completion date
2020-05-14
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

D-dimers, Atrial fibrillation

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.

Interventions

PROCEDUREBlood 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.

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
D-dimers concentrationfirst day of hospitalizationConcentration of D-dimers in the blood

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026