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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
  Purpose

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)

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

Resource links provided by NLM:


Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: June 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Baseline level of biomarkers Other: Inflammatory biomarkers
tTst blood samples for cardiac biomarkers at baseline, 24-hours and 3 month post-ablation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Atrial fibrillation patients undergoing catheter ablation

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148914

Locations
United States, Texas
St.David's Medical Center
Austin, Texas, United States, 78705
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
  More Information

No publications provided

Responsible Party: Andrea Natale, Executive medical director, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT01148914     History of Changes
Other Study ID Numbers: TCAI-IMPACT
Study First Received: June 21, 2010
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Cardiac Arrhythmia Research Foundation:
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)

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 23, 2014