Clinical Trial: Electrical Cardioversion of Recent Onset Atrial Fibrillation - Silent Thromboembolic Events, Reverse Atrial Remodeling

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Electrical Cardioversion of Recent Onset Atrial Fibrillation - a Study of Silent Thromboembolic Events, Reverse Atrial Electrical and Functional Remodeling Including Inflammatory, Neurohormonal and Th

Brief Summary: The purpose of this study is to study the effects of transthoracic electrical cardioversion for restoration of sinus rhythm in patients who present with recent onset atrial fibrillation, with regard to new silent cerebral thrombo-embolic lesions and cognitive function, as well as electrical and functional/structural reverse remodelling, and its effects on inflammatory changes / specific cardiac biomarkers, vasoactive peptides, coagulation activity, and active fibrinolysis.

Detailed Summary:

Working plan This study will give information about the incidence of silent cerebral thrombo-embolic events in patients with recent onset AF, a population which is expected to consist mostly of paroxysmal AF patients.

Patients with atrial fibrillation (AF) duration less than 48 hours and fulfilling inclusion and not exclusion criteria will be included in the study by a cardiologist on the day of cardioversion, and study nurse will be notified to plan for the investigations. The patient will undergo clinical examination, clinical history will be taken and blood sampling. Once 12 lead ECG, echocardiography, questionnaires, telemetry and MR have been done the patient will be electrically cardioverted After the cardioversion the patient will be subject to echocardiography of the heart again, blood-sampling, 12 lead ECG, and MR brain. The patient is discharged but will be studied by echocardiography of the heart and MR brain again on day 7 - 10. Thereafter the patient will be followed for 30 days - see flowchart.

The day of cardioversion is defined as Day 0.

3.1. ASSESSMENT OF REMODELING/REVERSE REMODELING 3.1.1. Electrical remodeling Standard 12-Lead electrocardiography (ECG) at every health care visit. (Day -1, Day 0 before and immediately after DCC, Day 0 at discharge, Day 7-10 and 30). Recorded with automatic analysis of intervals, Paper speed 50 mm/sec.

O Data to be collected: Rhythm, heart rate, P wave duration and amplitude.

3.1.2. Functional remodeling (Echocardiographic analysis) - App. 1. Left and right atrial dimensions and volumes 53. Global left atrial function, left atrial ejection fraction: (assessed by 2D and speckle tracking )53, 54 Left ventricular ejection fract
Sponsor: Uppsala University Hospital

Current Primary Outcome: Percentage of patients with new cerebral ischemic events detected by nuclear Magnetic Resonance Imaging (MRI) of the brain after direct current electrical cardioversion (DCC), summing up those detected within 24 hours and those at 7 - 10 days after DCC. [ Time Frame: Immediately after cardioversion of atrial fibrillation up to 10 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Cognitive function as assessed by Mini-mental test [ Time Frame: Day 0 prior to cardioversion, Day 7-10, Day 30 and when clinically evident cerebrovascular event ]
  Mini-Mental-Test (Mini Mental State Examination, Swedish version, MMSE)
• Cognitive function as assessed by Trail Making Test [ Time Frame: Day 0 prior to cardioversion, Day 7-10, Day 30 and when clinically evident cerebrovascular event ]
  Trail Making Test A och B (TMT A och B).
• Inflammatory markers [ Time Frame: Day 0 before (sample 1) and 4 plus 1 hours after cardioversion at time for MRI 2 before discharge (sample 2) and day 7-10 (sample 3). ]
  C-Reactive protein Interleukin-6
• Cardiac bio-markers [ Time Frame: Day 0 before (sample 1) and 4 plus 1 hours after cardioversion at time for MRI 2 before discharge (sample 2) and day 7-10 (sample 3). ]
  • High-sensitivity cardiac troponin T (hsTnT),
  • N-terminal pro-brain natriuretic peptide (NT-proBNP)
• Coagulation activity [ Time Frame: Day 0 before (sample 1) and 4 plus 1 hours after cardioversion at time for MRI 2 before discharge (sample 2) and day 7-10 (sample 3). ]
  Markers for coagulation activity, reflecting effect of electric cardioversion
• Active fibrinolysis markers. [ Time Frame: Day 0 before (sample 1) and 4 plus 1 hours after cardioversion at time for MRI 2 before discharge (sample 2) and day 7-10 (sample 3). ]
  Markers for Active fibrinolysis, reflecting effect of electric cardioversion
• Cerebral damage [ Time Frame: Day 0 before (sample 1) and 4 plus 1 hours after cardioversion at time for MRI 2 before discharge (sample 2) and day 7-10 (sample 3). ]
  o Brain damage marker S100
• Echocardiographic Atrial parameters [ Time Frame: Day before and immediately after Cardioversion, Day 0 at discharge, Day 7-10 and 30 after Cardioversion. ]
  Left and right atrial dimensions and function
• Echocardiographic left ventricular parameters [ Time Frame: Day before and immediately after Cardioversion, Day 0 at discharge, Day 7-10 and 30 after Cardioversion. ]
  Left ventricular dimensions and function
• Atrial electrical remodeling parameters. [ Time Frame: Day before and immediately after DCC, Day 0 at discharge, Day 7-10 and 30 after DCC. ]
  P-wave
• Number of new cerebral ischemic events detected on MRI after electrical cardioversion, summing up those detected within 24 hours and those at 7 - 10 days after DCC [ Time Frame: Before and directly after cardioversion, and after 7-10 days. ]
  Brain MRI
• Sinus node recovery [ Time Frame: Day 0, after DC cardioversion ]
  Time to first P-wave after DC
• Atrial fibrillation relapse [ Time Frame: Through study completion, an average of 30 days ]

Original Secondary Outcome: Same as current

Information By: Uppsala University Hospital

Dates:
Date Received: September 17, 2015
Date Started: February 2015
Date Completion: December 2017
Last Updated: May 7, 2017
Last Verified: May 2017