Relationship Between Fibroblast Growth Factor 23 and Recurrence of Atrial Fibrillation After Catheter Ablation (REBECCA)
The Relationship Between Fibroblast Growth Factor 23 and the Recurrence of Atrial Fibrillation After Catheter Ablation: a Nested Case-Control Study
調査の概要
詳細な説明
Atrial fibrillation, which can result in stroke and thromboembolism in an approximately 5-fold increased risk, has been a great burden to health care system with the aging of population. Catheter ablation is the most promising treatment of atrial fibrillation. However, the recurrence rates of AF after catheter ablation are high, ranging from 20%-60%. Therefore, non-invasive predictors for AF recurrence after catheter ablation is necessary to select the optimal patients for this procedure.
Fibroblast growth factor-23 (FGF-23) is a bone-derived hormone that plays a central role in phosphate homeostasis. Recent study showed that fibroblast growth factor 23 plays an important role in cardiac remodeling and is considered to be independently associated with the occurrence of atrial fibrillation. In this study, we are going to observe the relationship between the serum FGF-23 and the arrythmia recurrence after catheter ablation of AF.
This research is going to recruit 200 consecutive patients with a history of atrial fibrillation for 180-360 days who intend to undergo catheter ablation. The day before catheter ablation, serum FGF-23 level will be detected. Echocardiogram and left atrial CT scan will also be performed on the day before catheter ablation. All patients will be routinely follow up in the outpatient department by cardiologists every month for 1 year. If patients complain about palpitations, fatigue, or other symptoms related to arrhythmia, Holter monitoring will be performed. Patients will also be advised to see their doctor anytime they have these symptoms and to undergo a 12-lead ECG examination or 24-hour Holter monitoring. In asymptomatic patients, 24-hour Holter monitoring or 7-day cardiac event recording will be performed every three months after the procedure. The endpoint for follow-up is the recurrence of atrial fibrillation, which is considered to be any episode of AF/AFL/AT after a blank period of 3 months after the procedure of catheter ablation. Those who develop recurrence of AF during follow up will be assigned to recurrence group, and those who do not develop recurrence of AF during follow up will be assigned to non-recurrence group. Comparison of the serum FGF-23 level between the two groups will be carried out in order to investigate the relationship between serum FGF-23 level and the recurrence of AF.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Beijing
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Beijing、Beijing、中国、100019
- Peking University Third Hospital
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Have a history of atrial fibrillation for 180 to 360 days
- Provide written informed consent, having understood the benefits and risks of participation in the trial
Exclusion Criteria:
- Significant structural heart disease (including symptomatic coronary heart disease; prosthetic mitral or tricuspid valve; congenital heart disease where abnormality or its correction prohibits or increases the risk of ablation)
- Atrial Fibrillation precipitated by other diseases (such as thyrotoxicosis)
- Severe dysfunction of liver or kidney
- Diabetes
- Malignant tumor
- Inability or refusal to provide written informed consent for the study
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
- 観測モデル:ケースコントロール
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
Recurrence Group
In the case control trial, patients who have any episode of atrial fibrillation/atrial flutter/atrial tachycardia after a blanking period of 3 months from the catheter ablation procedure will be assign to the recurrence group
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Patients with persistent or paroxysmal atrial fibrillation will go through catheter ablation
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Non-recurrence Group
In the case control trial, patients who do not have any episode of atrial fibrillation/atrial flutter/atrial tachycardia after a blanking period of 3 months from the catheter ablation procedure will be assign to the recurrence group
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Patients with persistent or paroxysmal atrial fibrillation will go through catheter ablation
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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 |
メジャーの説明 |
時間枠 |
---|---|---|
Incidence of the recurrence of atrial fibrillation
時間枠:after 3 months from the procedure of catheter ablation
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The recurrence of atrial fibrillation is considered to be any episode of AF/AFL/AT after a blank period of 3 months after the procedure of catheter ablation
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after 3 months from the procedure of catheter ablation
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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 |
---|---|---|
Plasma fibroblast growth factor 23 levels
時間枠:after 3 months from the procedure of catheter ablation
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Fibroblast Growth Factor 23 plays an important role in cardiac remodeling and is considered to be independently associated with the occurrence of atrial fibrillation
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after 3 months from the procedure of catheter ablation
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CHA2DS2-VASc score
時間枠:after 3 months from the procedure of catheter ablation
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CHA2DS2-VASc score is used to measure the risk of thrombotic event in patient with atrial fibrillation
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after 3 months from the procedure of catheter ablation
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Cardiac CT evaluation
時間枠:after 3 months from the procedure of catheter ablation
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To evaluate the degree of fibrosis of the left and right atrium and pulmonary veins
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after 3 months from the procedure of catheter ablation
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協力者と研究者
捜査官
- スタディディレクター:Lei Li, MD、Peking University Third Hospital
出版物と役立つリンク
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 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Catheter ablationの臨床試験
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