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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

Tracking Information
First Submitted Date October 3, 2014
First Posted Date October 21, 2014
Last Update Posted Date December 14, 2017
Study Start Date June 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 16, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 16, 2014)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Enhanced Diagnostics for Early Detection of Atrial Fibrillation
Official Title Enhanced Diagnostics for Early Detection of Atrial Fibrillation - DETECT AF Trial
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.

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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
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.
Condition Atrial Fibrillation
Intervention Device: ECG
Patients receive a 5 Minute ECG recording and have their pulse recorded by an iPhone.
Study Groups/Cohorts Paroxysmal Af
No Intervention is planned. All patients receive a 5 Minute ECG and have their pulse recordes by an iPhone.
Intervention: Device: ECG
Publications * Brasier N, Engelter S, Kolbitsch T, Tabord A, Knobeloch J, Kühne M, Conen D, Traenka C, Kreutzberger T, Völlmin 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 16, 2015)
287
Original Estimated Enrollment
 (submitted: October 16, 2014)
300
Actual Study Completion Date October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • paroxysmal atrial fibrillation in sinus rhythm at presentation

Exclusion Criteria:

  • acute cerebral trauma
  • antiarrhythmic medication
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02270112
Other Study ID Numbers EKNZ:2014-080
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jens Eckstein, University Hospital, Basel, Switzerland
Study Sponsor University Hospital, Basel, Switzerland
Collaborators Not Provided
Investigators
Principal Investigator: Jens Eckstein, MD, PhD Universityhospital Basel
PRS Account University Hospital, Basel, Switzerland
Verification Date December 2017