The Role of Cardiac Biomarkers in Prediction of Outcome in Atrial Fibrillation Patients Undergoing Catheter Ablation (IMPACT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT01148914
First received: June 21, 2010
Last updated: May 31, 2012
Last verified: June 2010

June 21, 2010
May 31, 2012
June 2010
April 2012   (final data collection date for primary outcome measure)
To identify serum biomarkers that correlate with procedure outcome in AF patients undergoing catheter ablation [ Time Frame: 3-months post-procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01148914 on ClinicalTrials.gov Archive Site
  • To identify the biomarkers which correlate with different types of AF, namely paroxysmal, persistent or long-standing persistent [ Time Frame: 3months from the date of procedure ] [ Designated as safety issue: No ]
  • To identify candidate biomarkers that can predict fluid retention in the immediate post-ablation period. [ Time Frame: 24 hours from the procedure date ] [ Designated as safety issue: No ]
  • To identify the biomarkers which correlate with different types of AF, namely paroxysmal, persistent or long-standing persistent [ Designated as safety issue: No ]
  • To identify candidate biomarkers that can predict fluid retention in the immediate post-ablation period. [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Role of Cardiac Biomarkers in Prediction of Outcome in Atrial Fibrillation Patients Undergoing Catheter Ablation
The Role of Cardiac Biomarkers in Prediction of Outcome in Atrial Fibrillation Patients Undergoing Catheter Ablation

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)

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Atrial fibrillation patients undergoing catheter ablation

Atrial Fibrillation
Other: Inflammatory biomarkers
tTst blood samples for cardiac biomarkers at baseline, 24-hours and 3 month post-ablation
Baseline level of biomarkers
Intervention: Other: Inflammatory biomarkers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: 18-75 years
  • Patients undergoing catheter ablation of atrial fibrillation
  • Able and willing to give written consent

Exclusion Criteria:

  • Reversible causes of AF such as pericarditis and hyperthyroidism
  • Associated chronic inflammatory diseases such as chronic gingivitis or peri-odontitis, rheumatoid Arthritis, IBD including Ulcerative Colitis and Crohn's disease, Lupus, Ankylosing Spondylitis, COPD, psoriasis, vasculitis
  • Patients taking long-term steroid medication
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01148914
TCAI-IMPACT
No
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
Texas Cardiac Arrhythmia Research Foundation
Not Provided
Not Provided
Texas Cardiac Arrhythmia Research Foundation
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP