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

18 de junio de 2021 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

320

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Seoul, Corea, república de
        • Yonsei University Health system, Severance Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Comparador activo: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in cognitive function, depression, and anxiety scale after catheter ablation or drug treatment after 1 year of randomization
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 1 year
Compasison of scale change using the GAD-7 questionnaire.
1 year

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Differences according to AF type
Periodo de tiempo: 1year
1year
Differences in adverse effects of ablation vs. medications
Periodo de tiempo: 1year
1year
Differences in MACE, Death, and Readmission rate
Periodo de tiempo: 1year
1year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Hui-Nam Pak, Yonsei University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

1 de junio de 2021

Finalización primaria (Anticipado)

23 de febrero de 2026

Finalización del estudio (Anticipado)

23 de febrero de 2026

Fechas de registro del estudio

Enviado por primera vez

26 de mayo de 2021

Primero enviado que cumplió con los criterios de control de calidad

18 de junio de 2021

Publicado por primera vez (Actual)

28 de junio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de junio de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

18 de junio de 2021

Última verificación

1 de junio de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 4-2020-1488

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Indeciso

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Fibrilación auricular

Ensayos clínicos sobre Atrial fibrillation catheter ablation group

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