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

NCT02955004 | Completed

• 1 other identifier: UppsalaUH
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 3

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.

Conditions

Intracranial Embolism

Keywords

silent brain embolism; atrial fibrillation; cardioversion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Cognitive function as assessed by Mini-mental test

  Day 0 prior to cardioversion, Day 7-10, Day 30 and when clinically evident cerebrovascular event

• Cognitive function as assessed by Trail Making Test

  Day 0 prior to cardioversion, Day 7-10, Day 30 and when clinically evident cerebrovascular event

• Inflammatory markers

  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).

• Cardiac bio-markers

  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).

• Coagulation activity

  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).

Interventions

Electrical cardioversion PROCEDURE

Transthoracic direct current electrical cardioversion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who present to the emergency department or the outpatient clinic with recent onset atrial fibrillation (defined as atrial fibrillation duration less than 48 hours), are eligible for the study.

You may qualify if:

• Atrial fibrillation of recent onset (less than 48 hours) ongoing at time for baseline MRI.
• Age: 18-75 years

You may not qualify if:

• Recent (less than 3 months) cardioversion of AF or atrial flutter
• Previous clinical cerebrovascular event
• Congestive heart failure New York Heart Association (NYHA) function class III and IV
• Previously documented moderate or severely decreased left ventricular ejection fraction (LVEF less than 35%)
• Previously documented marked mitral regurgitation or stenosis
• Atrial flutter, atypical atrial flutter or intra-atrial re-entry tachycardia
• Contraindications to electrical cardioversion
• Permanent implanted cardiac device (event recorders accepted)
• Contraindication to nuclear magnetic resonance imaging (MRI) - see separate list addendum 1.
• Known coagulation defects or spontaneous INR or activated partial thromboplastin time (APTT) levels at therapeutic levels
• Current Vitamin K antagonists (VKA) or Novel Oral Anticoagulation (NOAC) treatment
• Spontaneous conversion to sinus rhythm prior to first MRI

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Swedish Heart Lung Foundation: collaborator
• Advanz Pharma: collaborator

Study Sites (3)

Dept of Cardiology, Gävle lasarett

Gävle, 80187, Sweden

Location

Dept of Cardiology, Södersjukhuset, Karolinska Institute

Stockholm, 118 83, Sweden

Location

Department of Cardiology, University Hospital in Uppsala

Uppsala, 75185, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CRP P- von Willebrandfaktor- antigen P- Interleukin-6 \[IL-6\] P- Fibrin, D-dimer S- N-terminalt pBNP P- Troponin I Pt(Lkc)- Faktor V, genotyp S- Heparin/PF4-antikroppar P-Protrombinfragment 1+2 P-selectin factor VIII:C Brain marker S100

MeSH Terms

Conditions

Intracranial Embolism; Atrial Fibrillation

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Carina M Blomstrom Lundqvist, MD, PhD

  Department of Cardiology, Institution of Medical Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, senior consultant

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: November 4, 2016
• Study Start: February 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 17, 2019

Record last verified: 2019-09

Locations

SE (3)