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

NCT01148914 | Completed

• 1 other identifier: TCAI-IMPACT
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study aims;

1. 1.To assess if pre-ablation levels of inflammatory biomarkers serve as independent predictors of procedure outcome
2. 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. 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. 4.To study the association of certain biomarkers with specific types of AF (paroxysmal or persistent or long standing persistent)

Conditions

Atrial Fibrillation

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)

Outcome Measures

Primary Outcomes (1)

• To identify serum biomarkers that correlate with procedure outcome in AF patients undergoing catheter ablation

  3-months post-procedure

Secondary Outcomes (2)

• To identify the biomarkers which correlate with different types of AF, namely paroxysmal, persistent or long-standing persistent

  3months from the date of procedure

• To identify candidate biomarkers that can predict fluid retention in the immediate post-ablation period.

  24 hours from the procedure date

Study Arms (1)

Baseline level of biomarkers

Other: Inflammatory biomarkers

Interventions

Inflammatory biomarkers OTHER

tTst blood samples for cardiac biomarkers at baseline, 24-hours and 3 month post-ablation

Baseline level of biomarkers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Atrial fibrillation patients undergoing catheter ablation

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Cardiac Arrhythmia Research Foundation: lead

Study Sites (1)

St.David's Medical Center

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive medical director

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 22, 2010
• Study Start: June 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 1, 2012

Record last verified: 2010-06

Locations

US (1)