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

Sponsor

Brugmann University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02802488

Collaborator

(none)

142

Enrollment

Location

Arm

46.4

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: Blood sampling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

142 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

May 14, 2020

Actual Study Completion Date :

May 14, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: D-dimers This arm encompasses patients between 18 and 80 years old and diagnosed with atrial fibrillation.	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.

Arm

Intervention/Treatment

Experimental: D-dimers

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

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.

Outcome Measures

Primary Outcome Measures

D-dimers concentration [first day of hospitalization]
Concentration of D-dimers in the blood

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Brugmann	Brussels		Belgium	1020

Sponsors and Collaborators

Brugmann University Hospital

Investigators

Principal Investigator: José Castro, MD, CHU Brugmann
Principal Investigator: Alexandre Almorad, MD, CHU Brugmann

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

José Castro, Head of clinic, Brugmann University Hospital

ClinicalTrials.gov Identifier:

NCT02802488

Other Study ID Numbers:

CHUB-ADDIT-AF

First Posted:

Jun 16, 2016

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by José Castro, Head of clinic, Brugmann University Hospital

D-dimers

Atrial fibrillation

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Jul 20, 2022