Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000771358
Ethics application status
Approved
Date submitted
9/05/2017
Date registered
26/05/2017
Date last updated
22/04/2020
Date data sharing statement initially provided
6/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Identifying the differences in the blood chemistry, electrical and structural properties of the heart between participants with and without prior strokes.
Scientific title
Identifying differences in blood biochemistry, cardiac electrophysiological and structural properties between stroke patients and an age matched control group without stroke
Secondary ID [1] 291886 0
Nil Known
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record
No

Health condition
Health condition(s) or problem(s) studied:
Stroke 303176 0
Heart Disease 303177 0
Atrial Fibrillation 303178 0
Thromboembolism 303193 0
Condition category
Condition code
Cardiovascular 302619 302619 0 0
Coronary heart disease
Stroke 302620 302620 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Exposures of interest are blood biochemistry and the cardiac electrical and structural changes in patients with stroke and comparing them to an age matched control patient cohort without a history of stroke. All measurements will be single point measurements, with no long term component.
Exposures:
1) Blood biochemistry: Peripheral and intra cardiac blood samples
2) Cardiac structure: Transthoracic and Transoesophageal echocardiography
3) Cardiac electrical properties: Assessed using 12 lead ECG, Invasive cardiac electrophysiology study.
Intervention code [1] 298014 0
Early Detection / Screening
Comparator / control treatment
Control population will be age matched patients without a prior history of stroke.
Control group
Active

Outcomes
Primary outcome [1] 302041 0
Primary Outcome : Difference between stroke and control groups in echocardiographic parameters as a composite of left atrial volumetric function, left atrial size and left atrial strain.
Timepoint [1] 302041 0
Stroke group to undergo an echocardiogram within 3 months of the index stroke
Primary outcome [2] 302042 0
Primary Outcome : Difference between stroke and control groups with regards to blood markers of inflammation, thrombogenesis and endothelial function.

Composite of IL-6, hsCRP, Thormbin/Antithrombin complex, D-Dimer, ADMA, Von Willebrand Factor, Pro-ntBNP, hsTroponin,

Timepoint [2] 302042 0
The biomarkers will be collected from stroke patients within 3 months of index stroke.
Primary outcome [3] 302043 0
Primary Outcome : Difference between stroke and control groups in electrical substrate

Timepoint [3] 302043 0
Stroke patients will undergo electrophysiologic testing within 6 months of index event.
Control group will be assessed during routine indicated electrophysiologic studies.
Secondary outcome [1] 335218 0
Compare ectopic burden between stroke and control groups as assessed by total number of premature atrial complexes in 24 hours of Holter monitoring.
Timepoint [1] 335218 0
Single point measure within 3 months of stroke.
Control group will be recruited during routine indicated 24 hour monitoring.

Eligibility
Key inclusion criteria
Stroke group: Admission diagnosis of ischaemic stroke or TIA, older than 55 years of age
Control group: Age matched patients without prior history of stroke or TIA
Minimum age
55 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Unable to provide informed consent
2. Pregnancy
3. Chronic kidney disease; stage 4 or greater
4. Patients with significant ventricular arrhythmias on extended monitoring

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis
Data will be presented as proportions, means and standard deviations, medians with inter-quartile range. Differences between groups will be assessed by a two-sided Chi-Squared Test or Fisher’s Exact Test for categorical data as appropriate. A Two-sided student’s T-Test or a non-parametric Wilcoxon Rank Sum Test will be used to compare continuous data as appropriate. A p-value < 0.05 will be considered to indicate statistical significance.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/06/2017
Actual
23/01/2018
Date of last participant enrolment
Anticipated
30/10/2020
Actual
Date of last data collection
Anticipated
30/11/2020
Actual
Sample size
Target
150
Accrual to date
130
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7972 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 7973 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 15944 0
3128 - Box Hill
Recruitment postcode(s) [2] 15945 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 296382 0
Hospital
Name [1] 296382 0
Box Hill Hospiital
Country [1] 296382 0
Australia
Funding source category [2] 296404 0
University
Name [2] 296404 0
Monash University
Country [2] 296404 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton, VIC 3800
Country
Australia
Secondary sponsor category [1] 295330 0
Hospital
Name [1] 295330 0
Box Hill Hospital
Address [1] 295330 0
5 Arnold St, Box Hill, VIC 3128
Country [1] 295330 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297620 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 297620 0
5 Arnold street, Box Hill, VIC 3128
Ethics committee country [1] 297620 0
Australia
Date submitted for ethics approval [1] 297620 0
26/04/2016
Approval date [1] 297620 0
11/04/2017
Ethics approval number [1] 297620 0
E07-2016

Summary
Brief summary
Atrial fibrillation (AF) is a fast irregular heart rate that can cause abnormalities in the structure and electrical function of the heart and can cause strokes through formation of blood clots in the heart which move to the brain. A stroke is when blood flow to the brain is interrupted. Although AF is known to increase the risk of stroke, there is new evidence that suggests that other factors may be independently present that cause formation of blood clots in the heart leading to a stroke.

The primary purpose of this study is to identify changes in structure of the heart, the electrical properties within the heart and in the blood chemistry that might increase a person’s risk for having a stroke.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74614 0
Dr Andrew Teh
Address 74614 0
Department of Cardiology, Box Hill Hospital, Eastern Health, 5 Arnold Street, Box Hill, VIC 3128
Country 74614 0
Australia
Phone 74614 0
+61 3 9895 4833
Fax 74614 0
Email 74614 0
[email protected]
Contact person for public queries
Name 74615 0
Dr Jithin Sajeev
Address 74615 0
Department of Cardiology, Box Hill Hospital, Eastern Health, 5 Arnold Street, Box Hill, VIC 3128
Country 74615 0
Australia
Phone 74615 0
+61 3 9895 4833
Fax 74615 0
Email 74615 0
[email protected]
Contact person for scientific queries
Name 74616 0
Dr Andrew Teh
Address 74616 0
Department of Cardiology, Box Hill Hospital, Eastern Health, 5 Arnold Street, Box Hill, VIC 3128
Country 74616 0
Australia
Phone 74616 0
+61 3 9895 4833
Fax 74616 0
Email 74616 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
Unable to share data at this time due to hospital privacy guidelines


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.