Cognitive Function in Patients With Persisted Atrial Fibrillation

Cognitive Function Clinical Trial

— SMART-AF  

Official title:

The Best Treatment Strategy for the Reservation of Cognitive Function in Patients With Persisted Atrial Fibrillation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04508491
• Other study ID #: 201912175RINC
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare the difference of cognitive function between different treatment strategy in patients with persistent atrial fibrillation

Description:

The prevalence of atrial fibrillation (AF) had been increasing for the past decade. The increase of AF was attributed to the aging of the population and the increased awareness of the disease among people and the primary physicians. However, we have not achieved the consensus whether aggressive rhythm control or conservative rate control is better in a patient with asymptomatic persisted AF. We do prescribe anti-coagulant for stroke prevention, but which treatment strategy is best for the patients is uncertain. The clinical trial of catheter-based ablation for rhythm control compared to traditional medication control has not shown the benefit of reducing all-cause mortality, but it did show a reduction of re-hospitalization and the recurrence of AF. On the contrary, the study in heart failure patients had shown a significant benefit applying catheter-based rhythm control strategy to reduce all-cause mortality. The different results of these two trials told us the benefit of rhythm control is not easily to be seen in a short-term, but could be seen in a long term or in high risk patients. The association between AF and cognitive impairment has also been reported in observation cohort. However, there is no sold evidence in clinical trials to show the improvement of cognitive function by treating atrial fibrillation. One study did show improvement of cognitive function with questionnaire, but the other showed new lesion detected by traditional magnetic resonance imaging (MRI) after ablation, though the lesion resolved after one year of follow-up. There is no clear answer to which treatment strategy is better for the patients' cognitive function。 Therefore, we designe a prospective, randomized, blind endpointtrial. We will enroll the patients with persisted AF, and use advanced MRI (DTI/SWI) and questionnaire to longitudinally study the cognitive function change of the patients before and after the initiation of anti-coagulant agents, before and after the catheter-based ablation, and use this as a surrogate to understand the best treatment strategy for these AF patients.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Those who meet the diagnosis of persistent atrial fibrillation, meet one of the

following conditions:

• The twelve-lead electrocardiogram is used to diagnose atrial fibrillation, and to cooperate with clinical diagnosis.
• 24 hours ECG diagnosis 100% atrial fibrillation, with clinical diagnosis.
• The seven-day ECG recorder diagnosed 100% atrial fibrillation.

2. Willing to accept treatment recommended by doctors, containing anticoagulant, and cooperate with examination and treatment in the coming year.

Exclusion Criteria:

1. Unwilling to sign the clinical trial consent form.

2. Unable to complete the cognitive function questionnaire.

3. Unable to complete brain MRI examination due to various reasons

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Persistent
• Cognitive Function

Intervention

Other:
• Rhythm control
Rhythm control with medications or any procedure
• Rate control
Rate control

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function	MOCA questionnaire	12 months
Primary	Cognitive function	brain MRI	12 months
Secondary	Quality of Life questionnaire	SF-36 questionnaire	12 months
Secondary	Hospitalization for cardiovascular cause		12 months
Secondary	all cause mortality		12 months