Enhanced Diagnostics for Early Detection of Atrial Fibrillation

NCT02270112 | Completed

• 1 other identifier: EKNZ:2014-080
• Study Type: observational
• Target: 287
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; atrial electrophysiology; stroke; vascular stiffness

Outcome Measures

Primary Outcomes (1)

• 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.

  Once during the exam (baseline) - No further follow up planned

Secondary Outcomes (3)

• Averaged slope of pressure-curve

  Once during exam (5min, baseline) - No further follow up planned

• Averaged slope of pressure-curve

  Once during exam (5min, baseline) - No further follow up planned

• Heart rate variability

  Once during exam (5min, baseline) - No further follow up planned

Study Arms (1)

Paroxysmal Af

No Intervention is planned. All patients receive a 5 Minute ECG and have their pulse recordes by an iPhone.

Device: ECG

Interventions

ECG DEVICE

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

Paroxysmal Af

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• paroxysmal atrial fibrillation in sinus rhythm at presentation

You may not qualify if:

• acute cerebral trauma
• antiarrhythmic medication

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 30122130 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Jens Eckstein, MD, PhD

  Universityhospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 21, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 14, 2017

Record last verified: 2017-12

Locations

CH (1)