Characterization of endothelial function, arterial stiffness and inflammation in Atrial Fibrillation: Effect of cardioversion

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000642684

Enrollment

Registered

2014-06-18

Start date

2014-06-20

Completion date

2015-06-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to investigate if restoring sinus rhythm in patients with atrial fibrillation by cardioversion is associated with impairment of endothelial function, arterial stiffness and inflammation. The hypotheses to be tested include: 1) Restoration of sinus rhythm by cardioversion will adversely affect endothelial function, arterial stiffness and inflammation. 2) The length of time patients remain in sinus rhythm will correlate significantly with changes in endothelial function, arterial stiffness and inflammation.

Interventions

Electrical cardioversion Cardioversion will be performed on patients who were fasted for up to eight hours prior to the procedure. Patients will be sedated with midazolam and a 150J biphasic shock will be used to reset SR. Patients will be closely monitored by trained staff for the duration of the procedure and discharged when clinically stable and fully recovered from sedation (within 1.5 hours post cardioversion for all patients).

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

This study will consist of evaluating patients who are undergoing a therapy directed at restoring sinus rhythm, ie. electrical cardioversion; patients of both sexes aged > 18 yrs meeting the following criteria will be enrolled. Consecutive patients with AF undergoing elective cardioversion at the Royal Adelaide Hospital or Wakefield Hospital will be eligible for this study. Endothelial function testing will be performed pre and 2 hours post procedure.

Exclusion criteria

Patients will be excluded if they have known causes of acute AF (such as pneumonia or other infections, alcohol excess, pulmonary embolism), significant heart valve disease, acute cardiovascular or cerebrovascular events (myocardial infarction, acute coronary syndrome or stroke) within the last 3 months, malignancy, connective tissue disease, chronic infection, inflammatory conditions, renal or hepatic dysfunction. We will exclude patients who, for any reason, are contra-indicated to undergo cardioversion of AF. As a final exclusion, patients unable to undergo a brief general anaesthetic will not be enrolled.

Outcome results