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OpenTrials
Completed

NCT Number: NCT02270112

Enhanced Diagnostics for Early Detection of Atrial Fibrillation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • paroxysmal atrial fibrillation in sinus rhythm at presentation

Exclusion criteria

  • acute cerebral trauma
  • antiarrhythmic medication

Treatment and study plan

ECG

Device

Patients receive a 5 Minute ECG recording and have their pulse recorded by an iPhone.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Enhanced Diagnostics for Early Detection of Atrial Fibrillation - DETECT AF Trial

Acronym: DETECT-AF

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 21, 2014
Registry last updated
Dec 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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