Atrial FibrillationIMPACTNCT01148914
The Role of Cardiac Biomarkers in Prediction of Outcome in Atrial Fibrillation Patients Undergoing Catheter Ablation
An observational study of Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Inflammatory biomarkers
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Atrial fibrillation patients undergoing catheter ablation
Who may be able to join
- Age: 18-75 years
- Patients undergoing catheter ablation of atrial fibrillation
- Able and willing to give written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This prospective study aims;
- 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 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
- To study the association of certain biomarkers with specific types of AF (paroxysmal or persistent or long standing persistent)
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Inflammatory biomarkers
- 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)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflammatory biomarkersOther
tTst blood samples for cardiac biomarkers at baseline, 24-hours and 3 month post-ablation
| Study group | Role | What they receive |
|---|---|---|
| Baseline level of biomarkers | Not described Receives: Other: Inflammatory biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify serum biomarkers that correlate with procedure outcome in AF patients undergoing catheter ablation
Measured: 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
Measured: 3months from the date of procedure
To identify candidate biomarkers that can predict fluid retention in the immediate post-ablation period.
Measured: 24 hours from the procedure date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148914
- Sponsor's protocol ID
- TCAI-IMPACT
- Acronym
- IMPACT
- Status last verified
- Jun 2010
- First submitted
- 21 Jun 2010
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cardiac Biomarkers in Prediction of Outcome in Atrial Fibrillation Patients Undergoing Catheter Ablation
- ClinicalTrials.gov ID
- NCT01148914
- Acronym / sponsor ID
- IMPACT / TCAI-IMPACT
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study aims;
- 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 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
- To study the association of certain biomarkers with specific types of AF (paroxysmal or persistent or long standing persistent)
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baseline level of biomarkers | – | Other: Inflammatory biomarkers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Atrial fibrillation patients undergoing catheter ablation
Key inclusion criteria (3 listed)
- Age: 18-75 years
- Patients undergoing catheter ablation of atrial fibrillation
- Able and willing to give written consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inflammatory biomarkerstTst blood samples for cardiac biomarkers at baseline, 24-hours and 3 month post-ablation | Other | Baseline level of biomarkers |
Primary outcome
To identify serum biomarkers that correlate with procedure outcome in AF patients undergoing catheter ablation
Time frame: 3-months post-procedure
2 secondary outcomes
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
To identify candidate biomarkers that can predict fluid retention in the immediate post-ablation period.
Time frame: 24 hours from the procedure date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify serum biomarkers that correlate with procedure outcome in AF patients undergoing catheter ablation (time frame: 3-months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012.