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Enhanced Diagnostics for Early Detection of Atrial Fibrillation (DETECT-AF)

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ClinicalTrials.gov Identifier: NCT02270112
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Jens Eckstein, University Hospital, Basel, Switzerland

Brief 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.


Condition or disease Intervention/treatment
Atrial Fibrillation Device: ECG

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

  1. Electrophysiological differences between patients with paroxysmal AF and no history of AF
  2. "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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 287 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Enhanced Diagnostics for Early Detection of Atrial Fibrillation - DETECT AF Trial
Study Start Date : June 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Paroxysmal Af
No Intervention is planned. All patients receive a 5 Minute ECG and have their pulse recordes by an iPhone.
Device: ECG
Patients receive a 5 Minute ECG recording and have their pulse recorded by an iPhone.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Averaged slope of pressure-curve [ Time Frame: Once during exam (5min, baseline) - No further follow up planned ]
    Test if the steepness of the slope of the pressure curve recorded with the iPhone differs between the two Groups.

  2. Averaged slope of pressure-curve [ Time Frame: Once during exam (5min, baseline) - No further follow up planned ]
    Test if the steepness of the slope of the pressure curve recorded with the iPhone correlates with cardiovascular risk factors.

  3. Heart rate variability [ Time Frame: Once during exam (5min, baseline) - No further follow up planned ]
    Test if heart rate variability recorded with the iPhone differs between the two Groups.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • paroxysmal atrial fibrillation in sinus rhythm at presentation

Exclusion Criteria:

  • acute cerebral trauma
  • antiarrhythmic medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270112


Locations
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Switzerland
University Hospital Basel
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Jens Eckstein, MD, PhD Universityhospital Basel
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jens Eckstein, MD, PhD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02270112    
Other Study ID Numbers: EKNZ:2014-080
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Keywords provided by Jens Eckstein, University Hospital, Basel, Switzerland:
atrial fibrillation
atrial electrophysiology
stroke
vascular stiffness
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes