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Clinical Trials/NCT02802488
NCT02802488
Completed
Not Applicable

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

Brugmann University Hospital1 site in 1 country142 target enrollmentJuly 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Brugmann University Hospital
Enrollment
142
Locations
1
Primary Endpoint
D-dimers concentration
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2016
End Date
May 14, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

José Castro

Head of clinic

Brugmann University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

D-dimers concentration

Time Frame: first day of hospitalization

Concentration of D-dimers in the blood

Study Sites (1)

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