Atrial FibrillationDETECT-AFNCT02270112
Enhanced Diagnostics for Early Detection of Atrial Fibrillation
An observational study of Atrial Fibrillation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Paroxysmal atrial fibrillation can only be diagnosed during episodes when the arrhythmia is present. The investigators hypothesize that the activation of the atrial myocardium resulting in the p-wave of the ecg should display abnormalities in diseased atria which are vulnerable for AF. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ECG
- Type of treatment
- Medical device
- How many people
- 287 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2014to Oct 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All inhospital and outpatient patients of our Institution with known paroxysmal AF are screened for eligebility. Control Group is equally recruted from patients of our intitution matching the studygroup.
Who may be able to join
- paroxysmal atrial fibrillation in sinus rhythm at presentation
Who cannot join
- acute cerebral trauma
- antiarrhythmic medication
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Enhanced Diagnostics for Early Detection of Atrial Fibrillation - DETECT AF Trial
Paroxysmal atrial fibrillation can only be diagnosed during episodes when the arrhythmia is present.
The investigators hypothesize that the activation of the atrial myocardium resulting in the p-wave of the ecg should display abnormalities in diseased atria which are vulnerable for AF.
Read the detailed description
In the first part of this trial different diagnostic techniques to detect arrythmogenic substrates of atrial fibrillation will be tested. If suitable parameters can be identified, a follow up trial to identify patients at risk for AF will be conducted before a stroke happens.
Parameters tested are
- Electrophysiological differences between patients with paroxysmal AF and no history of AF
- "Vascular Stiffness" detected by an iPhone app
All patients will undergo a cardiogoniometrie and a pulse wave analysis with an iPhone. Each exam takes 5 minutes.
- Conditions
- Atrial Fibrillation
- Being tested
- ECG
- Keywords
- atrial fibrillation, atrial electrophysiology, stroke, vascular stiffness
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDevice
Patients receive a 5 Minute ECG recording and have their pulse recorded by an iPhone.
| Study group | Role | What they receive |
|---|---|---|
| Paroxysmal Af | No Intervention is planned. All patients receive a 5 Minute ECG and have their pulse recordes by an iPhone. Receives: Device: ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beat to beat variation of the electrical activation vector of the atrium
Test if the beat to beat Variation of the electrical activation of the atrium differentiates between the group of patients with paroxysmal AF and no AF in history.
Measured: Once during the exam (baseline) - No further follow up planned
Secondary outcomes (3)
Averaged slope of pressure-curve
Test if the steepness of the slope of the pressure curve recorded with the iPhone differs between the two Groups.
Measured: Once during exam (5min, baseline) - No further follow up planned
Averaged slope of pressure-curve
Test if the steepness of the slope of the pressure curve recorded with the iPhone correlates with cardiovascular risk factors.
Measured: Once during exam (5min, baseline) - No further follow up planned
Heart rate variability
Test if heart rate variability recorded with the iPhone differs between the two Groups.
Measured: Once during exam (5min, baseline) - No further follow up planned
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 287 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Eckstein, University Hospital, Basel, Switzerland
- Investigators
- Jens Eckstein, MD, PhD, Principal investigator, Universityhospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270112
- Sponsor's protocol ID
- EKNZ:2014-080
- Acronym
- DETECT-AF
- Status last verified
- Dec 2017
- First submitted
- 3 Oct 2014
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Brasier N, Engelter S, Kolbitsch T, Tabord A, Knobeloch J, Kuhne M, Conen D, Traenka C, Kreutzberger T, Vollmin G, Eckstein J. The quest for indicators of paroxysmal atrial fibrillation in sinus rhythm - the DETECT AF trial. Acta Cardiol. 2019 Aug;74(4):301-307. doi: 10.1080/00015385.2018.1493248. Epub 2018 Aug 19.
PubMed 30122130
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Diagnostics for Early Detection of Atrial Fibrillation - DETECT AF Trial
- ClinicalTrials.gov ID
- NCT02270112
- Acronym / sponsor ID
- DETECT-AF / EKNZ:2014-080
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, atrial electrophysiology, stroke, vascular stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 21 Oct 2014 (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.
Paroxysmal atrial fibrillation can only be diagnosed during episodes when the arrhythmia is present.
The investigators hypothesize that the activation of the atrial myocardium resulting in the p-wave of the ecg should display abnormalities in diseased atria which are vulnerable for AF.
Detailed description
In the first part of this trial different diagnostic techniques to detect arrythmogenic substrates of atrial fibrillation will be tested. If suitable parameters can be identified, a follow up trial to identify patients at risk for AF will be conducted before a stroke happens.
Parameters tested are
- Electrophysiological differences between patients with paroxysmal AF and no history of AF
- "Vascular Stiffness" detected by an iPhone app
All patients will undergo a cardiogoniometrie and a pulse wave analysis with an iPhone. Each exam takes 5 minutes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paroxysmal Af | – | Device: ECGNo Intervention is planned. All patients receive a 5 Minute ECG and have their pulse recordes by an iPhone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All inhospital and outpatient patients of our Institution with known paroxysmal AF are screened for eligebility. Control Group is equally recruted from patients of our intitution matching the studygroup.
Key inclusion criteria (1 listed)
- paroxysmal atrial fibrillation in sinus rhythm at presentation
Key exclusion criteria (2 listed)
- acute cerebral trauma
- antiarrhythmic medication
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 |
|---|---|---|
| ECGPatients receive a 5 Minute ECG recording and have their pulse recorded by an iPhone. | Device | Paroxysmal Af |
Primary outcome
Beat to beat variation of the electrical activation vector of the atrium
Time frame: Once during the exam (baseline) - No further follow up planned
Test if the beat to beat Variation of the electrical activation of the atrium differentiates between the group of patients with paroxysmal AF and no AF in history.
3 secondary outcomes
Averaged slope of pressure-curve
Time frame: Once during exam (5min, baseline) - No further follow up planned
Averaged slope of pressure-curve
Time frame: Once during exam (5min, baseline) - No further follow up planned
Heart rate variability
Time frame: Once during exam (5min, baseline) - No further follow up planned
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 14 Dec 2017.
- Derived from this study: PubMed 30122130Brasier N, Engelter S, Kolbitsch T, Tabord A, Knobeloch J, Kuhne M, Conen D, Traenka C, Kreutzberger T, Vollmin G, Eckstein J. The quest for indicators of paroxysmal atrial fibrillation in sinus rhythm - the DETECT AF trial. Acta Cardiol. 2019 Aug;74(4):301-307. doi: 10.1080/00015385.2018.1493248. Epub 2018 Aug 19.
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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.
Jens Eckstein, MD, PhD principal investigator
Universityhospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 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 14 Dec 2017. 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 Switzerland. 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?
Beat to beat variation of the electrical activation vector of the atrium (time frame: Once during the exam (baseline) - No further follow up planned). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02270112, which also lists 1 linked publication.
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 14 Dec 2017.