Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001460190
Ethics application status
Approved
Date submitted
23/09/2019
Date registered
22/10/2019
Date last updated
1/03/2023
Date data sharing statement initially provided
22/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does asymptomatic Atrial Fibrillation lead to Cognitive Decline? An observational (non intervention) study of participants with Subclinical Atrial Fibrillation and possible decline in memory function.
Scientific title
Cognitive Decline in Subclinical Atrial Fibrillation. An observational prospective study characterising cognitive decline in patients with Subclinical Atrial Fibrillation.
Secondary ID [1] 298806 0
Nil known
Universal Trial Number (UTN)
U1111-1237-3705
Trial acronym
CogSAFe study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Decline 314099 0
Condition category
Condition code
Mental Health 312475 312475 0 0
Studies of normal psychology, cognitive function and behaviour
Cardiovascular 312476 312476 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational prospective longitudinal study.
Exposed group: Patients presenting with device detected Subclinical Atrial Fibrillation will be assessed for Cognitive Function/Cognitive Decline over a period of 3 years. The AF burden greater than or equal to 0.5% and at least one episode greater than or equal to 6.0 hours during any 6 month period will be included in exposed group.
Those with subclinical AF with burden less than specified will be followed up separately in a registry.
Medical Records will be accessed by study staff to confirm eligibility for trial and study participation for all participants will involve an initial assessment by a Cardiologist who will perform pacemaker interrogation. This assessment is followed by an Echo cardiogram, cognitive assessments and quality of life surveys at enrollment and 3 years post enrollment. There is an optional blood test for Biomarker analysis at enrolment. MRI scans will be offered at 3 years post enrolment.
Intervention code [1] 315337 0
Not applicable
Comparator / control treatment
Unexposed population : Consecutive patients with CIEDs and absence of documented AF on Device in last 12 months.

The controls with AF detected subsequently will be excluded from analysis and followed up separately in a registry.
Control group
Active

Outcomes
Primary outcome [1] 321117 0
Cognitive Impairment in participants with Sub Clinical Atrial Fibrillation will be assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) which makes age specific recommendations.
Timepoint [1] 321117 0
Baseline and 3 years post enrollment
Secondary outcome [1] 374041 0
Incidence of sub clinical infarcts on brain MRI as defined according to STRIVE criteria in participants with SCAF.
Timepoint [1] 374041 0
3 years post enrollment
Secondary outcome [2] 375379 0
Incidence of white matter hyper densities on brain MRI as defined according to STRIVE criteria in participants with SCAF.
Timepoint [2] 375379 0
3 years post enrollment
Secondary outcome [3] 375580 0
Incidence of micro bleeds on brain MRI as defined according to STRIVE criteria in participants with SCAF
Timepoint [3] 375580 0
3 years post enrollment
Secondary outcome [4] 376029 0
Composite Outcome of Clinical Diagnosis of Transient Ischemic Attack (TIA) or Embolic Stroke (TOAST criteria)
Timepoint [4] 376029 0
3 years post enrollment
Secondary outcome [5] 376030 0
Secondary Outcome assessing changes in quality of life associated with SCAF compared to participants without SCAF, These changes in quality of life are measured using the
Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire.
Timepoint [5] 376030 0
Baseline and 3 years post enrollment
Secondary outcome [6] 376031 0
Secondary Outcome assessing changes in quality of life associated with SCAF compared to participants without SCAF, These changes in quality of life are measured using the Short Form Survey (SF36) questionnaire
Timepoint [6] 376031 0
Baseline and 3 years post enrollment
Secondary outcome [7] 376106 0
Secondary Outcome assessing changes in quality of life associated with SCAF compared to participants without SCAF, These changes in quality of life are measured using the Centre for Epidemiological Studies Depression Scale (CES-D) questionnaire.
Timepoint [7] 376106 0
Baseline and 3 years post enrollment
Secondary outcome [8] 376109 0
Biomarker for exploratory analysis via serum assay
Timepoint [8] 376109 0
Enrollment

Eligibility
Key inclusion criteria
Patients undergoing a CIED implant or clinical review of previously implanted CIED in outpatients or private clinic
Age 60-85 years old
CHA2DS2-Vasc score (non gender) greater than or equal to 2
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previously diagnosed Atrial Fibrillation
Contraindication for Brain MRI
Patients due to undergo Cardiac Implantable Electronic Devices replacement
Valvular Severe Mitral Valve Disease
Oral Anticoagulant Use
Absent functional lead in pacemaker
Parkinson's Disease
Alzheimer's Disease
Aphasia
Severe Psychiatric Disorder
An inability to provide informed consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Power calculations for the study are based on existing literature that characterised cognitive impairment in patients with AF using RBANS assessments. Sample size was calculated based on 80% statistical power to detect a difference in mean RBANS scores between the two study groups 0.3 times the standard deviation of the distribution of RBANS scores, using a two sample t test, two sided with significant level alpha of 0.05. Sample sizes were calculated using mean score for each domain tested by the RBANS with the greatest sample size being n=194 per group, which allows for a 10% loss to follow up. Conservative recruitment target is therefore 200 participants in study group and 200 in control group.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2019
Actual
18/03/2020
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
1/11/2024
Actual
Sample size
Target
400
Accrual to date
100
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 14600 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 24160 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 27619 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 29628 0
5112 - Elizabeth
Recruitment postcode(s) [3] 29629 0
5067 - Norwood
Recruitment postcode(s) [4] 35369 0
5035 - Ashford
Recruitment postcode(s) [5] 39692 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 303362 0
University
Name [1] 303362 0
University of Adelaide
Country [1] 303362 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Faculty of Health and Medical Sciences
University of Adelaide
North Terrace
Adelaide
SA 5005
Country
Australia
Secondary sponsor category [1] 303695 0
None
Name [1] 303695 0
Address [1] 303695 0
Country [1] 303695 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303892 0
Central Adelaide Local Health Network
Ethics committee address [1] 303892 0
Royal Adelaide Hospital, North Terrace, Adelaide SA 5000
Ethics committee country [1] 303892 0
Australia
Date submitted for ethics approval [1] 303892 0
01/03/2019
Approval date [1] 303892 0
12/04/2019
Ethics approval number [1] 303892 0
HREC/19/CALHN/114

Summary
Brief summary
The study explores the idea whether subclinical AF (SCAF) is associated with risk of dementia and is a longitudinal prospective study conducted over 3 years in patients with Cardiac Implantable Electronic Devices (CIED's) inserted.
The study group will consist of 200 patients with SCAF and CHA2DS2-Vasc score (non-gender) of greater than or equal to 2. The control group will consist of 200 patients with documented absence of AF and CHA2DS2-Vasc score (non-gender) of greater than or equal to 2. All participants will undergo neurocognitive testing and quality of life questionnaires and optional brain Magnetic Resonance Imaging to assess for cerebral changes at study completion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95150 0
Dr Rajiv Mahajan
Address 95150 0
University of Adelaide Precinct
Level 2
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale 5112
SA
Country 95150 0
Australia
Phone 95150 0
+61 8 8182 9439
Fax 95150 0
Email 95150 0
[email protected]
Contact person for public queries
Name 95151 0
Dr Rajiv Mahajan
Address 95151 0
University of Adelaide Precinct
Level 2
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale 5112
SA
Country 95151 0
Australia
Phone 95151 0
+61 8 8182 9439
Fax 95151 0
Email 95151 0
[email protected]
Contact person for scientific queries
Name 95152 0
Dr Rajiv Mahajan
Address 95152 0
University of Adelaide Precinct
Level 2
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale 5112
SA
Country 95152 0
Australia
Phone 95152 0
+61 8 8182 9439
Fax 95152 0
Email 95152 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not planned at this timepoint


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.