Atrial FibrillationNCT02802488
Age Related D-dimer Evaluation for the Exclusion of a Left Atrium Thrombus in Patients With Atrial Fibrillation (ADDIT-AF)
A study testing Blood sampling in people with Atrial Fibrillation, run by Brugmann University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2016to 14 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with de novo or recent atrial fibrillation requiring cardioversion, either by drug, by an electric shock or an intervention.
Who cannot join
- valvulopathy
- infection
- neoplasia
- inflammatory disease
- recent surgery
- pregnancy
Show all 9Show fewer
- aorta aneurism
- deep vein thrombosis
- pulmonary embolism
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Blood sampling
- Keywords
- D-dimers, Atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| D-dimers | Experimental | This arm encompasses patients between 18 and 80 years old and diagnosed with atrial fibrillation. Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
D-dimers concentration
Concentration of D-dimers in the blood
Measured: first day of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start1 Jul 2016
- Primary completion14 May 2020
- Study completion14 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Castro, Brugmann University Hospital
- Investigators
- José Castro, MD, Principal investigator, CHU BrugmannAlexandre Almorad, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802488
- Sponsor's protocol ID
- CHUB-ADDIT-AF
- Status last verified
- Jul 2022
- First submitted
- 13 Jun 2016
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age Related D-dimer Evaluation for the Exclusion of a Left Atrium Thrombus in Patients With Atrial Fibrillation (ADDIT-AF)
- ClinicalTrials.gov ID
- NCT02802488
- Acronym / sponsor ID
- CHUB-ADDIT-AF
- Conditions
- Atrial Fibrillation
- Keywords
- D-dimers, Atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D-dimers | Experimental | Procedure: Blood samplingThis arm encompasses patients between 18 and 80 years old and diagnosed with atrial fibrillation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with de novo or recent atrial fibrillation requiring cardioversion, either by drug, by an electric shock or an intervention.
Key exclusion criteria (9 listed)
- valvulopathy
- infection
- neoplasia
- inflammatory disease
- recent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingA 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. | Procedure or surgery | D-dimers |
Primary outcome
D-dimers concentration
Time frame: first day of hospitalization
Concentration of D-dimers in the blood
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Castro, MD principal investigator
CHU Brugmann
Alexandre Almorad, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Atrial Fibrillation, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
D-dimers concentration (time frame: first day of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.