Impact of Anxiety on Cardiac Substrate Modification in Women With Atrial Fibrillation Undergoing Catheter Ablation (AWARE)
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Texas
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Austin、Texas、アメリカ、78705
- 募集
- Texas Cardiac Arrhythmia Institute, St. david's Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age: ≥ 18 years
- Sex: female
- Undergoing catheter ablation for paroxysmal or persistent AF
- Able and willing to provide written informed consent
Exclusion Criteria:
- Receiving behavioral therapy or medications for the anxiety disorder
- On hormonal supplement
- On long-term steroid or anti-inflammatory drugs
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:Group 1: with baseline anxiety+catheter ablation
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
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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
他の名前:
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アクティブコンパレータ:Group 2: Without baseline anxiety + catheter ablation
Cardiac Anxiety Questionnaire (CAQ) score <2.14 Hospital Anxiety and Depression Questionnaire (HAD) <7 State-Trait Anxiety Inventory (STAI): State-anxiety score <40
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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
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Correlation between baseline anxiety score and prevalence of left atrial scar and non-pulmonary vein triggers
時間枠:intraoperative
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intraoperative
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Correlation of baseline anxiety score with scar severity
時間枠:intraoperative
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intraoperative
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Correlation of baseline TWBC and CRP level with the anxiety score
時間枠:baseline
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baseline
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Change in CAQ score
時間枠:12 months
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12 months
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Recurrence status
時間枠:1 year
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Recurrence of AF/ AFlutter/ atrial tachycardia off or on anti-arrhythmic drugs
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1 year
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Change in HAD score
時間枠:12 months
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12 months
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Change in State-anxiety
時間枠:12 months
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12 months
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協力者と研究者
捜査官
- 主任研究者:Mitra Mohanty, MD MS FHRS、Texas Cardiac Arrhythmia Research Foundation
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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Catheter ablationの臨床試験
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Boston Scientific Corporation完了
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Pier LambiaseUniversity Hospital Southampton NHS Foundation Trust; The Royal Bournemouth Hospital完了
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BrosMed Medical Co., LtdCCRF Inc., Beijing, Chinaわからない
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University of AdelaideBoston Scientific Corporation; Medtronic; Abbott Medical Devices完了