EMOTIon and COgNitive Function After Atrial Fibrillation Catheter Ablation vs. Medical Therapy(EMOTICON Trial)
EMOTIon and COgNitive Function After Atrial Fibrillation Catheter Ablation vs. Medical Therapy; Randomized Clinical Trial (EMOTICON Trial)
"Atrial fibrillation (AF) is an arrhythmic disease that increases especially in the elderly, increasing the risk of ischemic stroke by 5 times and is a major cause of dementia and cognitive impairment.
Cognitive dysfunction accompanying AF occurs regardless of the presence or absence of stroke, and AF itself is known to affect cognitive function.
However, since cognitive dysfunction is also affected by various accompanying chronic diseases, whether the cognitive dysfunction accompanying AF is due to subclinical ischemic stroke, cerebral hypoperfusion due to reduced cardiac output, inflammatory reaction or platelet dysfunction are unclear.
Recently, this research team reported an improvement in cognitive function with active sinus rhythm therapy such as AF catheter ablation. Nevertheless, it has not yet been proven whether such active and invasive AF treatment affects the improvement of cognitive function or depression by a randomized clinical trial.
In this prospective randomized clinical comparative study, the investigators will compare the AF catheter ablation group and drug therapy group in terms of cognitive function tests and depression psychological tests at baseline and a year after treatment. Our hypothesis is that AF catheter ablation is superior to drug therapy to improve cognitive function and depressive mood.
調査の概要
詳細な説明
Study design
- Prospective randomization (catheter ablation group vs. drug treatment group) (Python program is used, the random number module is imported using the import random syntax, and the random number table of the two groups is prepared and used)
- Target number of targets 320 (160 for each group)
- Cardiac rhythm follow-up: 2012 ACC/AHA/ESC guidelines (baseline, 3 months, every 6 months after Holter, Electrocardiogram when symptoms are present)
- Anticoagulant therapy follows 2014 ACC/AHA/ESC guidelines.
- Evaluation of MOCA score (cognitive function), CES-D score (depression), and GAD-7 score (anxiety) at baseline and a year after treatment, respectively.
- Evaluation of all adverse events occurring in each group, hospitalization rate, major cardiovascular attack, and mortality rate comparison
Progress and rhythm/ ECG follow-up
- Implemented in accordance with 2012 ACC/AHA/HRS guidelines for AF management
- Baseline MOCA, CES-D, and GAD-7 score evaluation
- Outpatient follow-up observation 1 to 2 weeks after the start of the procedure or medication
- Follow-up observation at intervals of 2 months, 6 months, and then every 6 months after starting the procedure or medication
- If the patient complains of arrhythmia symptoms, conduct an electrocardiogram at any time, and follow the rhythm with a Holter or event recorder.
- Follow-up MOCA, CES-D, and GAD-7 score evaluation
Follow-up observation
- All patients are scheduled to visit the outpatient clinic every 6 months after 1~2 weeks, 2 months, 6 months, and even if they have symptoms in the middle, they will be treated as an outpatient at any time.
- An ECG is administered at every outpatient visit. A 24-hour Holter or event recorder was administered for 1 year at intervals of 2, 6, and 6 months after the procedure (2012 Heart Rhythm Society/EHRA/European Cardiac Arrhythmia Society Expert Consensus Statement guidelines).
- If atrial fibrillation or atrial tachycardia lasting more than 30 seconds is observed on a standard electrocardiogram, event electrocardiogram, or Holter, it is evaluated as recurrence. Recurrence within 3 months after the procedure is classified as early recurrence, and recurrence after 3 months is classified as clinical recurrence.
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
-
-
-
Seoul、大韓民国
- Yonsei University Health System, Severance 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
説明
Inclusion Criteria:
- Patients aged between 20 and 80 years of age who have appropriate indication for catheter ablation for AF
- AF patients with left atrium diameter <55 mm
- Antiarrhythmic drug-resistant AF
- Anticoagulation eligible patients
Exclusion Criteria:
- AF associated with severe cardiac malformation or structural heart disease
- Patients undergoing treatment for cognitive disorders, emotional disorders, and anxiety disorders
- Patients with severe renal dysfunction or difficulty in CT imaging using contrast media
- Patients with a previous history of AF ablation or other open heart surgery
- Patients with active internal bleeding
- Anticoagulant therapy not eligible patients
- Valvular AF (mitral valve stenosis>grade 2, mechanical valve, mitral valve reconstruction)
- Significant comorbidities
- Patients with an expected survival period of less than 1 year
- Drug or alcohol addiction patients
- Among eligible persons, those who cannot read the consent form (illiteracy, foreigners, etc.)
- Patients judged to be unsuitable for participation in clinical research based on the judgment of other researchers
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：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Atrial fibrillation catheter ablation group
catheter ablation
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|
|
アクティブコンパレータ：Medical therapy group
standard treatment include anti-arrhythmic drug
|
|
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 |
|---|---|---|
|
Changes in cognitive function, depression, and anxiety scale after catheter ablation or drug treatment after 1 year of randomization
時間枠：1 year
|
Compasison of scale change using the Moca questionnaire.
|
1 year
|
|
Changes in depression scale after catheter ablation or drug treatment after 1 year of randomization
時間枠：1 year
|
Compasison of scale change using the CES-D questionnaire.
|
1 year
|
|
Changes in anxiety scale after catheter ablation or drug treatment after 1 year of randomization
時間枠：1 year
|
Compasison of scale change using the GAD-7 questionnaire.
|
1 year
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Differences according to AF type
時間枠：1year
|
1year
|
|
Differences in adverse effects of ablation vs. medications
時間枠：1year
|
1year
|
|
Differences in MACE, Death, and Readmission rate
時間枠：1year
|
1year
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Hui-Nam Pak、Yonsei University
研究記録日
主要日程の研究
研究開始 (予想される)
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 (実際)
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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