Atrial FibrillationAWARENCT02547584
Impact of Anxiety on Cardiac Substrate Modification in Women With Atrial Fibrillation Undergoing Catheter Ablation
A study testing Catheter ablation in people with Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
Trial summary
This pilot study aims to assess the impact of anxiety on the cardiac substrate remodeling in female patients with paroxysmal and persistent atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jul 2022
- Phase
- Interventional
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥ 18 years
- Sex: female
- Undergoing catheter ablation for paroxysmal or persistent AF
- Able and willing to provide written informed consent
Who cannot join
- Receiving behavioral therapy or medications for the anxiety disorder
- On hormonal supplement
- On long-term steroid or anti-inflammatory drugs
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Cardiac Arrhythmia Institute, St. david's Medical Center
Austin, Texas, 78705
About this study
This pilot study aims to assess the impact of anxiety on the cardiac substrate remodeling in female patients with paroxysmal and persistent atrial fibrillation (AF).
Read the detailed description
Hypothesis: High level of anxiety promotes remodeling of cardiac substrate via persistent inflammation, resulting in an increase in the prevalence of left atrial scar and non-pulmonary vein (non-PV) triggers in women with AF.
Rationale: Anxiety is generally defined as a psycho-biological emotional state or reaction that consists of unpleasant feelings of tension, apprehension, nervousness, and worry, and activation of the autonomic nervous system. This disorder is typically more common in women than men. There is considerable evidence to suggest close interactions between anxiety and inflammation and inflammation and AF.
Earlier studies have documented strong association between anxiety and inflammation as shown by high levels of inflammatory biomarkers such as C-reactive protein (CRP), total white blood cell (TWBC) count, fibrinogen and interleukin-6 in patients with anxiety. Chronic inflammation results in structural remodeling of the atrial architecture such as fibrotic changes that supports genesis and perpetuation of AF. In cardiac fibrosis, myocytes coupled with fibroblasts can undergo early depolarization resulting in increased ectopic beats and repetitive firing leading to the origin of non-pulmonary vein (non-PV) drivers. Left atrial scar is another known consequence of cardiac fibrosis. Therefore, it is prudent to hypothesize that high level of anxiety for prolonged period results in structural remodeling of cardiac substrates evidenced by increased prevalence of left atrial scar and non-PV triggers in female patients with paroxysmal and persistent AF.
Scar and non-PV triggers are known independent predictors of arrhythmia recurrence in AF patients undergoing catheter ablation. Recurrences of AF, despite complete PV disconnection, strongly suggest an important possible role of these foci in serving as a source for the persistence of this arrhythmia. Altered conduction and barriers resulting from the atrial scar form the critical circuits for intra-atrial re-entry that promotes AF persistence.
Recent progress in technology and knowledge have provided better understanding and allowed the electrophysiologists to improve on the ablation procedure in order to make it more safe and effective. However, there are still scores of unanswered questions in this relatively young research domain, one of which is if anxiety impacts cardiac substrate remodeling that potentially influences ablation-outcome. Also, of note, anxiety affects how patients perceive their illness, particularly for women, and influence healthcare utilization and economic burden. Therefore, if the role of anxiety would be ascertained, timely intervention of the same would lead to improvement in the success rate of the ablation therapy in females that highly dominate this subset of AF population.
Study Design: This pilot study will prospectively enroll 152 consenting female patients undergoing catheter ablation for AF. Eligible patients will be enrolled after signing informed consent, approved by Institutional Review Board of the participating institution.
- Conditions
- Atrial Fibrillation
- Being tested
- Catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
Also called RFCA
Pulmonary vein antrum isolation (PVAI) plus entire posterior wall plus coronary sinus plus left part of the septum. This intervention will be received by all as standard of care
| Study group | Role | What they receive |
|---|---|---|
| Group 1: with baseline anxiety+catheter ablation | Active comparator | Baseline anxiety will be defined as; Cardiac Anxiety Questionnaire (CAQ) score >2.14 Hospital Anxiety and Depression Questionnaire (HAD) >7 State-Trait Anxiety Inventory (STAI): State-anxiety score >40 Receives: Procedure: Catheter ablation |
| Group 2: Without baseline anxiety + catheter ablation | Active comparator | Cardiac Anxiety Questionnaire (CAQ) score <2.14 Hospital Anxiety and Depression Questionnaire (HAD) <7 State-Trait Anxiety Inventory (STAI): State-anxiety score <40 Receives: Procedure: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between baseline anxiety score and prevalence of left atrial scar and non-pulmonary vein triggers
Measured: intraoperative
Secondary outcomes (6)
Correlation of baseline anxiety score with scar severity
Measured: intraoperative
Correlation of baseline TWBC and CRP level with the anxiety score
Measured: baseline
Change in CAQ score
Measured: 12 months
Recurrence status
Recurrence of AF/ AFlutter/ atrial tachycardia off or on anti-arrhythmic drugs
Measured: 1 year
Change in HAD score
Measured: 12 months
Change in State-anxiety
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2020 (estimated)
- Study completionJul 2022 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (estimated)
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
- Investigators
- Mitra Mohanty, MD MS FHRS, Principal investigator, Texas Cardiac Arrhythmia Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547584
- Sponsor's protocol ID
- TCAI_AWARE
- Acronym
- AWARE
- Status last verified
- Sep 2019
- First submitted
- 3 Sep 2015
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anxiety on Cardiac Substrate Modification in Women With Atrial Fibrillation Undergoing Catheter Ablation
- ClinicalTrials.gov ID
- NCT02547584
- Acronym / sponsor ID
- AWARE / TCAI_AWARE
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 11 Sep 2015 (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 pilot study aims to assess the impact of anxiety on the cardiac substrate remodeling in female patients with paroxysmal and persistent atrial fibrillation (AF).
Detailed description
Hypothesis: High level of anxiety promotes remodeling of cardiac substrate via persistent inflammation, resulting in an increase in the prevalence of left atrial scar and non-pulmonary vein (non-PV) triggers in women with AF.
Rationale: Anxiety is generally defined as a psycho-biological emotional state or reaction that consists of unpleasant feelings of tension, apprehension, nervousness, and worry, and activation of the autonomic nervous system. This disorder is typically more common in women than men. There is considerable evidence to suggest close interactions between anxiety and inflammation and inflammation and AF.
Earlier studies have documented strong association between anxiety and inflammation as shown by high levels of inflammatory biomarkers such as C-reactive protein (CRP), total white blood cell (TWBC) count, fibrinogen and interleukin-6 in patients with anxiety. Chronic inflammation results in structural remodeling of the atrial architecture such as fibrotic changes that supports genesis and perpetuation of AF. In cardiac fibrosis, myocytes coupled with fibroblasts can undergo early depolarization resulting in increased ectopic beats and repetitive firing leading to the origin of non-pulmonary vein (non-PV) drivers. Left atrial scar is another known consequence of cardiac fibrosis. Therefore, it is prudent to hypothesize that high level of anxiety for prolonged period results in structural remodeling of cardiac substrates evidenced by increased prevalence of left atrial scar and non-PV triggers in female patients with paroxysmal and persistent AF.
Scar and non-PV triggers are known independent predictors of arrhythmia recurrence in AF patients undergoing catheter ablation. Recurrences of AF, despite complete PV disconnection, strongly suggest an important possible role of these foci in serving as a source for the persistence of this arrhythmia. Altered conduction and barriers resulting from the atrial scar form the critical circuits for intra-atrial re-entry that promotes AF persistence.
Recent progress in technology and knowledge have provided better understanding and allowed the electrophysiologists to improve on the ablation procedure in order to make it more safe and effective. However, there are still scores of unanswered questions in this relatively young research domain, one of which is if anxiety impacts cardiac substrate remodeling that potentially influences ablation-outcome. Also, of note, anxiety affects how patients perceive their illness, particularly for women, and influence healthcare utilization and economic burden. Therefore, if the role of anxiety would be ascertained, timely intervention of the same would lead to improvement in the success rate of the ablation therapy in females that highly dominate this subset of AF population.
Study Design: This pilot study will prospectively enroll 152 consenting female patients undergoing catheter ablation for AF. Eligible patients will be enrolled after signing informed consent, approved by Institutional Review Board of the participating institution.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: with baseline anxiety+catheter ablation | Active comparator | Procedure: Catheter ablationBaseline anxiety will be defined as; Cardiac Anxiety Questionnaire (CAQ) score >2.14 Hospital Anxiety and Depression Questionnaire (HAD) >7 State-Trait Anxiety Inventory (STAI): State-anxiety score >40 |
| Group 2: Without baseline anxiety + catheter ablation | Active comparator | Procedure: Catheter ablationCardiac Anxiety Questionnaire (CAQ) score <2.14 Hospital Anxiety and Depression Questionnaire (HAD) <7 State-Trait Anxiety Inventory (STAI): State-anxiety score <40 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: ≥ 18 years
- Sex: female
- Undergoing catheter ablation for paroxysmal or persistent AF
- Able and willing to provide written informed consent
Key exclusion criteria (3 listed)
- Receiving behavioral therapy or medications for the anxiety disorder
- On hormonal supplement
- On long-term steroid or anti-inflammatory drugs
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 |
|---|---|---|
| Catheter ablationAlso: RFCAPulmonary vein antrum isolation (PVAI) plus entire posterior wall plus coronary sinus plus left part of the septum. This intervention will be received by all as standard of care | Procedure or surgery | Group 1: with baseline anxiety+catheter ablation, Group 2: Without baseline anxiety + catheter ablation |
Primary outcome
Correlation between baseline anxiety score and prevalence of left atrial scar and non-pulmonary vein triggers
Time frame: intraoperative
6 secondary outcomes
Correlation of baseline anxiety score with scar severity
Time frame: intraoperative
Correlation of baseline TWBC and CRP level with the anxiety score
Time frame: baseline
Change in CAQ score
Time frame: 12 months
Recurrence status
Time frame: 1 year
Change in HAD score
Time frame: 12 months
Change in State-anxiety
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Mitra Mohanty, MD MS FHRS principal investigator
Texas Cardiac Arrhythmia Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation in people with 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 4 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: status not confirmed, as of the sponsor's last update on 10 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mitra Mohanty, MD MS FHRS (512-544-8198, mitra1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between baseline anxiety score and prevalence of left atrial scar and non-pulmonary vein triggers (time frame: intraoperative). 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 10 Sep 2019.