Cognitive Function in Patients With Persisted Atrial Fibrillation (SMART-AF)
Primary Purpose
Atrial Fibrillation, Persistent, Cognitive Function
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Rhythm control
Rate control
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation, Persistent focused on measuring Atrial Fibrillation, Cognitive Function
Eligibility Criteria
Inclusion Criteria:
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.
- Willing to accept treatment recommended by doctors, containing anticoagulant, and cooperate with examination and treatment in the coming year.
Exclusion Criteria:
- Unwilling to sign the clinical trial consent form.
- Unable to complete the cognitive function questionnaire.
- Unable to complete brain MRI examination due to various reasons
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rhythm control
Rate control
Arm Description
Rhythm control with medication or any procedure
Rate control with medication or any procedure
Outcomes
Primary Outcome Measures
Cognitive function
MOCA questionnaire
Cognitive function
brain MRI
Secondary Outcome Measures
Quality of Life questionnaire
SF-36 questionnaire
Hospitalization for cardiovascular cause
all cause mortality
Full Information
NCT ID
NCT04508491
First Posted
August 9, 2020
Last Updated
April 17, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04508491
Brief Title
Cognitive Function in Patients With Persisted Atrial Fibrillation
Acronym
SMART-AF
Official Title
The Best Treatment Strategy for the Reservation of Cognitive Function in Patients With Persisted Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Compare the difference of cognitive function between different treatment strategy in patients with persistent atrial fibrillation
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Persistent, Cognitive Function
Keywords
Atrial Fibrillation, Cognitive Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rhythm control
Arm Type
Experimental
Arm Description
Rhythm control with medication or any procedure
Arm Title
Rate control
Arm Type
Active Comparator
Arm Description
Rate control with medication or any procedure
Intervention Type
Other
Intervention Name(s)
Rhythm control
Intervention Description
Rhythm control with medications or any procedure
Intervention Type
Other
Intervention Name(s)
Rate control
Intervention Description
Rate control
Primary Outcome Measure Information:
Title
Cognitive function
Description
MOCA questionnaire
Time Frame
12 months
Title
Cognitive function
Description
brain MRI
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of Life questionnaire
Description
SF-36 questionnaire
Time Frame
12 months
Title
Hospitalization for cardiovascular cause
Time Frame
12 months
Title
all cause mortality
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Willing to accept treatment recommended by doctors, containing anticoagulant, and cooperate with examination and treatment in the coming year.
Exclusion Criteria:
Unwilling to sign the clinical trial consent form.
Unable to complete the cognitive function questionnaire.
Unable to complete brain MRI examination due to various reasons
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Cognitive Function in Patients With Persisted Atrial Fibrillation
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