Intracranial Embolism Clinical Trial
— ECAF-STAROfficial title:
Electrical Cardioversion of Recent Onset Atrial Fibrillation - a Study of Silent Thromboembolic Events, Reverse Atrial Electrical and Functional Remodeling Including Inflammatory, Neurohormonal and Thromboembolic Biomarkers
NCT number | NCT02955004 |
Other study ID # | UppsalaUH |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2015 |
Est. completion date | December 2017 |
Verified date | September 2019 |
Source | Uppsala University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | December 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: Atrial fibrillation of recent onset (less than 48 hours) ongoing at time for baseline MRI. Age: 18-75 years Exclusion Criteria: 1. Recent (less than 3 months) cardioversion of AF or atrial flutter 2. Previous clinical cerebrovascular event 3. Congestive heart failure New York Heart Association (NYHA) function class III and IV 4. Previously documented moderate or severely decreased left ventricular ejection fraction (LVEF less than 35%) 5. Previously documented marked mitral regurgitation or stenosis 6. Atrial flutter, atypical atrial flutter or intra-atrial re-entry tachycardia 7. Contraindications to electrical cardioversion 8. Permanent implanted cardiac device (event recorders accepted) 9. Contraindication to nuclear magnetic resonance imaging (MRI) - see separate list addendum 1. 10. Known coagulation defects or spontaneous INR or activated partial thromboplastin time (APTT) levels at therapeutic levels 11. Current Vitamin K antagonists (VKA) or Novel Oral Anticoagulation (NOAC) treatment 12. Spontaneous conversion to sinus rhythm prior to first MRI |
Country | Name | City | State |
---|---|---|---|
Sweden | Dept of Cardiology, Gävle lasarett | Gävle | |
Sweden | Dept of Cardiology, Södersjukhuset, Karolinska Institute | Stockholm | |
Sweden | Department of Cardiology, University Hospital in Uppsala | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Uppsala University Hospital | Cardiome Pharma, Swedish Heart Lung Foundation |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | New cerebral ischemic events detected by MRI directly after cardioversion and after 7 - 10 Days, at which MRI are performed. | Immediately after cardioversion of atrial fibrillation up to 10 days | |
Secondary | Cognitive function as assessed by Mini-mental test | Mini-Mental-Test (Mini Mental State Examination, Swedish version, MMSE) | Day 0 prior to cardioversion, Day 7-10, Day 30 and when clinically evident cerebrovascular event | |
Secondary | Cognitive function as assessed by Trail Making Test | Trail Making Test A och B (TMT A och B). | Day 0 prior to cardioversion, Day 7-10, Day 30 and when clinically evident cerebrovascular event | |
Secondary | Inflammatory markers | C-Reactive protein Interleukin-6 | 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). | |
Secondary | Cardiac bio-markers | High-sensitivity cardiac troponin T (hsTnT), N-terminal pro-brain natriuretic peptide (NT-proBNP) |
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). | |
Secondary | Coagulation activity | Markers for coagulation activity, reflecting effect of electric cardioversion | 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). | |
Secondary | Active fibrinolysis markers. | Markers for Active fibrinolysis, reflecting effect of electric cardioversion | 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). | |
Secondary | Cerebral damage | o Brain damage marker S100 | 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). | |
Secondary | Echocardiographic Atrial parameters | Left and right atrial dimensions and function | Day before and immediately after Cardioversion, Day 0 at discharge, Day 7-10 and 30 after Cardioversion. | |
Secondary | Echocardiographic left ventricular parameters | Left ventricular dimensions and function | Day before and immediately after Cardioversion, Day 0 at discharge, Day 7-10 and 30 after Cardioversion. | |
Secondary | Atrial electrical remodeling parameters. | P-wave | Day before and immediately after DCC, Day 0 at discharge, Day 7-10 and 30 after DCC. | |
Secondary | 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 | Brain MRI | Before and directly after cardioversion, and after 7-10 days. | |
Secondary | Sinus node recovery | Time to first P-wave after DC | Day 0, after DC cardioversion | |
Secondary | Atrial fibrillation relapse | Through study completion, an average of 30 days |
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