The Role of Cardiac Biomarkers in Prediction of Outcome in Atrial Fibrillation Patients Undergoing Catheter Ablation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      This prospective study aims;

        1. To assess if pre-ablation levels of inflammatory biomarkers serve as independent
           predictors of procedure outcome

        2. To evaluate the inflammatory activation following catheter ablation by measuring
           serum-biomarker levels 24-hours after the procedure and examine the predictive role in
           procedure success

        3. To determine if a change in the baseline level of certain inflammatory biomarkers at
           3-months post-ablation period has any correlation with the long-term outcome in patients
           with atrial fibrillation

        4. To study the association of certain biomarkers with specific types of AF (paroxysmal or
           persistent or long standing persistent)
    

Detailed description: 
      AF is the most common arrhythmia in clinical practice, affecting > 2.3 million people in US.
      It increases dramatically with age and is seen in as many as 9% of individuals by the age of
      80 (1). A major cause of stroke, AF is also associated with a 2-fold increase in mortality
      (1).

      Symptomatic AF has been demonstrated to be consistently associated with elevated inflammatory
      activity in the atrial tissue as evidenced by the facts that AF occurs in 40% of patients
      following cardiac bypass surgery and 50% of patients undergoing valvular surgery (2). Recent
      studies have also demonstrated that elevated CRP level can increase the risk of AF up to 31%
      (2). Oxidative damage experienced during AF leads to myocardial necrosis which in turn
      induces low-grade inflammation resulting in eventual fibrosis of the atrial myocardium. Thus,
      inflammation can be responsible for adverse structural and electrical remodeling of the
      cardiac tissue which can further perpetuate the existence, maintenance, and recurrence of
      this arrhythmia.

      Radiofrequency catheter ablation (RFCA) has evolved as a promising curative therapy for
      drug-refractory AF. However, the recurrence of AF after RFCA is a common clinical problem,
      occurring in 25-50% of patients in the follow-up period (3) and some patients undergo
      multiple ablation procedures before being cured of the arrhythmia. Published retrospective
      studies have demonstrated that systemic inflammation generated during AF ablation is
      associated with fewer early arrhythmia recurrences (4). Therefore, measurement of
      inflammatory markers within 24 hours of RFCA could be helpful in further exploration of any
      association between the degree of inflammatory activation and procedure outcome.

      Systemic inflammatory activation is characterized by increased circulating levels of several
      biomarkers for prolonged periods. Thus, examination of these biomarkers at 3-months
      post-procedure may provide critical insight into understanding the role of inflammation in
      achievement of long-term success of catheter ablation in AF patients.

      Rules-Based Medicine, Inc (RBM) at 3300 Duval Road Austin, TX 78759 has developed biomarker
      panels that have been validated to detect early signs of inflammation. RBM will process the
      blood samples on a preliminary panel of ~40 biomarkers which are presumed to be possible
      predictors of procedural outcomes in RFCA in AF patients.
    

Intervention name(s): Inflammatory biomarkers
Intervention type(s): Other
Intervention description(s): tTst blood samples for cardiac biomarkers at baseline, 24-hours and 3 month post-ablation
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Atrial fibrillation patients undergoing catheter ablation
      
Keywords: Inflammatory biomarkers; Atrial fibrillation; Catheter ablation; To assess if pre-ablation levels of inflammatory biomarkers serve as independent predictors of procedure outcome; To evaluate the inflammatory activation following catheter ablation and examine its predictive role in procedure success; To determine if a change in the baseline level of biomarkers at 3-months follow-up has any correlation with long-term outcome; To study the association of certain biomarkers with specific types of AF (paroxysmal or persistent or long standing persistent)