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| Sponsor: | Texas Cardiac Arrhythmia Research Foundation |
|---|---|
| Information provided by: | Texas Cardiac Arrhythmia Research Foundation |
| ClinicalTrials.gov Identifier: | NCT01148914 |
Purpose
This prospective study aims;
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Other: Inflammatory biomarkers |
Phase 3 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | The Role of Cardiac Biomarkers in Prediction of Outcome in Atrial Fibrillation Patients Undergoing Catheter Ablation |
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Baseline level of biomarkers | Other: Inflammatory biomarkers |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Atrial fibrillation patients undergoing catheter ablation
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| St.David's Medical Center | Recruiting |
| Austin, Texas, United States, 78705 | |
| Contact: Mitra Mohanty, MD 512-544-8198 mitra.mohanty@stdavids.com | |
| Principal Investigator: Andrea Natale, MD, FACC, FHRS | |
More Information
| Responsible Party: | Andrea Natale, MD, FACC, FHRS/ Executive Medical Director of the Texas Cardiac Arrhythmia Institute, Texas Cardiac Arrhythmia Institute, St.David's Medical Center, Austin, Texas |
| ClinicalTrials.gov Identifier: | NCT01148914 History of Changes |
| Other Study ID Numbers: | TCAI-IMPACT |
| Study First Received: | June 21, 2010 |
| Last Updated: | June 21, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
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) |
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |