Age Related D-dimer Evaluation for the Exclusion of a Left Atrium Thrombus in Patients With Atrial Fibrillation (ADDIT-AF)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring D-dimers, Atrial fibrillation
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
Sites / Locations
- CHU Brugmann
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
D-dimers
Arm Description
This arm encompasses patients between 18 and 80 years old and diagnosed with atrial fibrillation.
Outcomes
Primary Outcome Measures
D-dimers concentration
Concentration of D-dimers in the blood
Secondary Outcome Measures
Full Information
NCT ID
NCT02802488
First Posted
June 13, 2016
Last Updated
July 18, 2022
Sponsor
Brugmann University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02802488
Brief Title
Age Related D-dimer Evaluation for the Exclusion of a Left Atrium Thrombus in Patients With Atrial Fibrillation (ADDIT-AF)
Official Title
Age Related D-dimer Evaluation for the Exclusion of a Left Atrium Thrombus in Patients With Atrial Fibrillation (ADDIT-AF)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
May 14, 2020 (Actual)
Study Completion Date
May 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
D-dimers, Atrial fibrillation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D-dimers
Arm Type
Experimental
Arm Description
This arm encompasses patients between 18 and 80 years old and diagnosed with atrial fibrillation.
Intervention Type
Procedure
Intervention Name(s)
Blood sampling
Intervention Description
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.
Primary Outcome Measure Information:
Title
D-dimers concentration
Description
Concentration of D-dimers in the blood
Time Frame
first day of hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Castro, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexandre Almorad, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Age Related D-dimer Evaluation for the Exclusion of a Left Atrium Thrombus in Patients With Atrial Fibrillation (ADDIT-AF)
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