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EMOTIon and COgNitive Function After Atrial Fibrillation Catheter Ablation vs. Medical Therapy(EMOTICON Trial)

2021年6月18日 更新者:Yonsei University

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.

研究概览

详细说明

Study design

  1. 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)
  2. Target number of targets 320 (160 for each group)
  3. Cardiac rhythm follow-up: 2012 ACC/AHA/ESC guidelines (baseline, 3 months, every 6 months after Holter, Electrocardiogram when symptoms are present)
  4. Anticoagulant therapy follows 2014 ACC/AHA/ESC guidelines.
  5. Evaluation of MOCA score (cognitive function), CES-D score (depression), and GAD-7 score (anxiety) at baseline and a year after treatment, respectively.
  6. Evaluation of all adverse events occurring in each group, hospitalization rate, major cardiovascular attack, and mortality rate comparison

Progress and rhythm/ ECG follow-up

  1. Implemented in accordance with 2012 ACC/AHA/HRS guidelines for AF management
  2. Baseline MOCA, CES-D, and GAD-7 score evaluation
  3. Outpatient follow-up observation 1 to 2 weeks after the start of the procedure or medication
  4. Follow-up observation at intervals of 2 months, 6 months, and then every 6 months after starting the procedure or medication
  5. If the patient complains of arrhythmia symptoms, conduct an electrocardiogram at any time, and follow the rhythm with a Holter or event recorder.
  6. 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.

研究类型

介入性

注册 (预期的)

320

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Seoul、大韩民国
        • Yonsei University Health system, Severance Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Patients aged between 20 and 80 years of age who have appropriate indication for catheter ablation for AF
  2. AF patients with left atrium diameter <55 mm
  3. Antiarrhythmic drug-resistant AF
  4. Anticoagulation eligible patients

Exclusion Criteria:

  1. AF associated with severe cardiac malformation or structural heart disease
  2. Patients undergoing treatment for cognitive disorders, emotional disorders, and anxiety disorders
  3. Patients with severe renal dysfunction or difficulty in CT imaging using contrast media
  4. Patients with a previous history of AF ablation or other open heart surgery
  5. Patients with active internal bleeding
  6. Anticoagulant therapy not eligible patients
  7. Valvular AF (mitral valve stenosis>grade 2, mechanical valve, mitral valve reconstruction)
  8. Significant comorbidities
  9. Patients with an expected survival period of less than 1 year
  10. Drug or alcohol addiction patients
  11. Among eligible persons, those who cannot read the consent form (illiteracy, foreigners, etc.)
  12. Patients judged to be unsuitable for participation in clinical research based on the judgment of other researchers

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Atrial fibrillation catheter ablation group
catheter ablation
  1. Pulmonary vein isolation
  2. Additional treatment for lesions caused by non-pulmonary veins
  3. Esophageal temperature monitoring to prevent damage to the esophagus
  4. Evaluation of procedure time and radiofrequency ablation time
  5. Evaluation of complications after the procedure
  6. Rhythm follow-up after the procedure is conducted in accordance with the above study design.
  7. Conduct a survey on cognitive function and emotion before and 12 months after the procedure
有源比较器:Medical therapy group
standard treatment include anti-arrhythmic drug
  1. Use of beta-blockers or calcium channel blockers for pulse rate control
  2. Antiarrhythmic drugs are administered to patients with highly symptomatic atrial fibrillation symptoms even after pulse rate control.
  3. If symptoms are not controlled even with antiarrhythmic drugs, electrical conversion to restore sinus rhythm.
  4. To prevent cerebral infarction, maintain optimal anticoagulant therapy according to the risk score for cerebral infarction.
  5. Conduct a questionnaire on cognitive function and emotion before and 12 months after the procedure

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Changes in cognitive function, depression, and anxiety scale after catheter ablation or drug treatment after 1 year of randomization
大体时间: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
大体时间: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
大体时间:1 year
Compasison of scale change using the GAD-7 questionnaire.
1 year

次要结果测量

结果测量
大体时间
Differences according to AF type
大体时间:1year
1year
Differences in adverse effects of ablation vs. medications
大体时间:1year
1year
Differences in MACE, Death, and Readmission rate
大体时间:1year
1year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Hui-Nam Pak、Yonsei University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2021年6月1日

初级完成 (预期的)

2026年2月23日

研究完成 (预期的)

2026年2月23日

研究注册日期

首次提交

2021年5月26日

首先提交符合 QC 标准的

2021年6月18日

首次发布 (实际的)

2021年6月28日

研究记录更新

最后更新发布 (实际的)

2021年6月28日

上次提交的符合 QC 标准的更新

2021年6月18日

最后验证

2021年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 4-2020-1488

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

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