Markers of Paroxysmal Atrial Fibrillation in Esophageal Holter Electrocardiography
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| First Received Date ICMJE | September 12, 2011 | ||||||||
| Last Updated Date | December 4, 2012 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number atrial premature beats not conducted to the ventricles [ Time Frame: during analysis of the ECG ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01436344 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Markers of Paroxysmal Atrial Fibrillation in Esophageal Holter Electrocardiography | ||||||||
| Official Title ICMJE | Markers of Paroxysmal Atrial Fibrillation in Esophageal Holter Electrocardiography | ||||||||
| Brief Summary | With the use of esophageal Holter electrocardiography (eECG), the investigators will look for surrogate markers of paroxysmal atrial fibrillation. To do so, the investigators will record eECGs in patients with known paroxysmal atrial fibrillation but at the time of eECG-recording in sinus rhythm. To identify markers, the eECGs of those patients will be compared to a group of controls in sinus rhythm without atrial fibrillation. The investigators hypothesis is that it is possible to identify surrogate markers in patients with paroxysmal atrial fibrillation. |
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| Detailed Description | Background The fast and correct diagnosis of heart rhythm disorders is very important to reduce morbidity and mortality in cardiovascular patients. Atrial fibrillation is of special interest, because it is an important cause of devastating brain strokes. A significant number of strokes has a cardioembolic genesis due to paroxysmal atrial fibrillation which was not diagnosed early enough. Therefore, it is very important to detect atrial fibrillation as soon as possible. With oral anticoagulation an effective therapeutic option in available to prevent cardioembolisms. In the clinical routine, mostly 24-hour or 7-day ECGs are made to look for cardiac arrhythmias. The use uf such devices is well established. Nevertheless, they have some side effects/limitations. Skin electrodes used for derivation of the ECG often cause skin irritation, sometimes leading to premature termination of the recording. Because of dryout of the contact gel (causes artifacts), small p-waves and especially also motion artifacts, triggered recording or semi-automatic analysis of the recording is problematic, but for longer recording times such a semi-automatic analysis would be helpful. As an alternative esophageal electrocardiography can be performed. Signal quality of the ECG recording (especially of the left atrium) is better than in the standard surface ECG because of the vicinity of the esophagus and the left atrium. The esophagus tolerates well foreign bodies as we know from long-term nasogastric intubation. Therefore use of the esophageal technique for long-term rhythm monitoring is an interesting and promising alternative to conventional surface Holter ECGs. The diagnosis of paroxysmal atrial fibrillation (pAF) can only be made if an episode of atrial fibrillation occurs during the long-term ECG recording. Surrogate markers of pAF could identify a "population at risk" in which pAF has to be suspected although they show sinus rhythm during the time of recording. In surface ECG such markers have been suspected. The use of esophageal long-term electrocardiography with its better signal properties is a promising alternative to find such surrogate markers for risk stratification. Objective Identification and characterization of surrogate markers indicative for pAF in patients with sinus rhythm at the time of recording. Methods A total of 60 patients will be included to identify and characterize surrogate markers for pAF. Cases with known pAF will consecutively be recruited from the cardiology ward and the cardiological ambulatory. After inclusion, an age (+/- one year) and gender adjusted control person without known pAF (negative 7-day ECG within the previous 365 days before study inclusion) will be matched to every patient. Cases and controls will receive a simultaneous 24-hour esophageal electrocardiography and standard surface electrocardiography. Controls without negative 7-day ECG within the past year will have to wear the surface ECG recorder for additional 6 days (total surface ECG recording of 7 days). In the case that paroxysmal atrial fibrillation is detected for the very first time during the study, patients will be allocated to the "case" group. Additionally, in all patients LA diameter parasternal will be measured echocardiographically. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | The study population consists of patients hospitalized on the cardiology ward (for any reasons). Additionally, also patients referred to the cardiology ambulatorium for a long-term ECG will be asked to participate the study. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Haeberlin A, Niederhauser T, Tanner H, Vogel R. Atrial waveform analysis using esophageal long-term electrocardiography reveals atrial ectopic activity. Clin Res Cardiol. 2012 Nov;101(11):941-2. doi: 10.1007/s00392-012-0477-6. Epub 2012 May 22. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | October 2013 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01436344 | ||||||||
| Other Study ID Numbers ICMJE | 084/11 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Rolf Vogel, MD, MD-PhD, University Hospital Bern, Dept. of Cardiology | ||||||||
| Study Sponsor ICMJE | University Hospital Inselspital, Berne | ||||||||
| Collaborators ICMJE | Commission for Technology and Innovation of the Swiss Federal Administration | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital Inselspital, Berne | ||||||||
| Verification Date | December 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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