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

NCT02802488 | Completed

• 1 other identifier: CHUB-ADDIT-AF
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

D-dimers; Atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• D-dimers concentration

  Concentration of D-dimers in the blood

  first day of hospitalization

Study Arms (1)

D-dimers

EXPERIMENTAL

This arm encompasses patients between 18 and 80 years old and diagnosed with atrial fibrillation.

Procedure: Blood sampling

Interventions

Blood sampling PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with de novo or recent atrial fibrillation requiring cardioversion, either by drug, by an electric shock or an intervention.

You may not qualify if:

• valvulopathy
• infection
• neoplasia
• inflammatory disease
• recent surgery
• pregnancy
• aorta aneurism
• deep vein thrombosis
• pulmonary embolism

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• José Castro, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

• Alexandre Almorad, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 16, 2016
• Study Start: July 1, 2016
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

BE (1)