Risk Profile for Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT01510197|
Recruitment Status : Completed
First Posted : January 16, 2012
Last Update Posted : July 28, 2015
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||503 participants|
|Official Title:||Identification of a Risk Profile in Patients With Atrial Fibrillation|
|Study Start Date :||September 2011|
|Primary Completion Date :||March 2015|
|Study Completion Date :||March 2015|
- assess the risk profile associated with success of rhythm control therapy at follow-up. [ Time Frame: 12 months ]1) < 1 second AF on end-of-study ECG; (2) < 30 seconds AF on end-of-study 48-hour Holter recording
- Time to recurrence of (a)symptomatic AF; [ Time Frame: 1+12+60 months ]by assessment Percentage AF-burden on 24-Holter during follow up
- Failure of rhythm control, i.e. permanent AF; [ Time Frame: 1+12+60 months ]<1 second AF on ECG during rhythm control medication or after electric cardioversion.
- Risk profiles associated with early versus late AF recurrence; [ Time Frame: 1+12+60 months ]Parameters including underlying (heart) disease and risk factors (age, family history for AF, signs of ischemia, coronary risk factors, pulmonary disease, diabetes, obesity, sleep apnea, esophageal problems), lifestyle (caffeine and alcohol intake, exercise), autonomic trigger patterns of AF (i.e. vagal or adrenergic induced AF, or combination)
- Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF [ Time Frame: 1+12+60 months ]3-lead Holter monitoring will be used
- Changes in atrial and ventricular echocardiographic parameters [ Time Frame: 1+12+60 month ]Echocardiographic measures of LA size (LA size parasternal long axis view, LA volume,LA ejection fraction measurement, electro-echocardiographic parameters (Tissue Doppler total atrial conduction time (during sinus rhythm), AF cycle length and velocity (during AF)), and parameters of diastolic dysfunction, including E (early mitral valve flow velocity), A (late mitral valve flow velocity), E/A ratio, deceleration time, E' (early tissue Doppler lengthening velocity), and E/E' ratio
- Cardiovascular morbidity and mortality [ Time Frame: 1+12+60 months ]hospitalization for cardiovascular reasons, non-cardiovascular and cardiovascular death will be carefully monitored through-out the study.
- Pulmonary vein ablation [ Time Frame: 1+12+60 months ]hospital admission for pulmonary vein ablation will be monitoring during the study.
- Differences in clinical profile and outcome between patients presenting at the emergency room and the outpatient department [ Time Frame: Baseline,12+60 months ]collected parameters will be compared between these two groups.
- relate risk profiles to quality of life [ Time Frame: 1+12+60 months ]a quality of life questionnaire will be handed
- biomarkers associated with success of rhythm control [ Time Frame: baseline, 12 months, 60 months ]biomarker profiles (collagen mediated, inflammation, neurohumoral) associated with underlying mechanism of AF
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): NCT01510197
|University Medical center Groningen|
|Groningen, Netherlands, 9700 RB|
|Principal Investigator:||Isabelle C van Gelder, Md PhD||University Medical Center Groningen|