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临床试验/NCT02208102
NCT02208102已完成不适用

Association of Cardiac Biomarkers With AF Ablation

Texas Cardiac Arrhythmia Research Foundation1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
155
试验地点
1
主要终点
Arrhythmia recurrence

研究概览

简要总结

The purpose of this study is to assess if pre-ablation levels of inflammatory biomarkers serve as independent predictors of procedure outcome 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 To study the association of certain biomarkers with specific types of AF (paroxysmal or persistent or long standing persistent)

详细描述

Specific Aim: The purpose of this prospective study is to evaluate the role of inflammatory biomarkers in predicting procedure-outcome in AF patients undergoing catheter ablation.

Background: 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.

Myriad Rules-Based Medicine, Inc (Myriad RBM) in Austin, TX 78759 has developed biomarker panels that have been validated to detect early signs of inflammation. Myriad RBM will process the blood samples on a preliminary panel of 77 biomarkers, identified to be possible predictors of procedural outcome in RFCA in AF patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 50-70 years
  • Patients undergoing catheter ablation of atrial fibrillation
  • Able and willing to give written consent

排除标准

  • 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
  • Any other co-morbid conditions except Diabetes and hypertension
  • Patients taking long-term anti-inflammatory, steroid medication, or immune suppression medication.

结局指标

主要结局

Arrhythmia recurrence

时间窗: 1 year

Patients will be monitored for arrhythmia recurrence for 1 year after the ablation procedure. At the end of the study, biomarker data will be analyzed to see any predictive association with AFib recurrence

次要结局

  • Left atrial scar(During ablation procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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