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Trial registered on ANZCTR


Registration number
ACTRN12620000435987
Ethics application status
Approved
Date submitted
17/03/2020
Date registered
2/04/2020
Date last updated
2/04/2020
Date data sharing statement initially provided
2/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Registry of Patients with Type B Aortic Syndromes
Scientific title
Type B aortic syndrome CLarifying the need for early Endovascular Aortic Repair (The B-CLEAR Registry)
Secondary ID [1] 300779 0
Nil known
Universal Trial Number (UTN)
U1111-1249-7872
Trial acronym
B-CLEAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type B aortic syndromes 316627 0
Condition category
Condition code
Cardiovascular 314865 314865 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of intervention(s) / exposure
Participants will be recruited from patients who present to Royal North Shore Hospital in Sydney, NSW, and are diagnosed with Type B Aortic Syndrome, whether complicated or uncomplicated. Informed consent will be obtained prior to registration. Data collection for the initial time point (baseline) will be for the duration of the initial hospital stay. This will record inpatient management.

Following discharge, patients will be followed up at specific timepoints (1 week, 3 months, 6 months, 12 months and annually thereafter) for the duration of the study (10 years). Patients will present for surveillance imaging prior to their appointment with their consultant vascular surgeon, or with a member of the research team. A quality-of-life questionnaire will also be completed at the same time. Follow up will take approximately 20 to 30 minutes.

The registry also aims to include patients who presented from January 2019. After ensuring patient's survival status, written informed consent will be obtained. Follow up data will be collected from the consultant surgeon's private practice and surveillance scans from radiology labs.
Intervention code [1] 317138 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323248 0
Survival duration after diagnosis with an aortic syndrome
Timepoint [1] 323248 0
Follow up timepoints:
baseline
one week
3 months
6 months
1 year
and every 12 months thereafter for 10 years (end of registry), unless deceased, or consent withdrawn
Secondary outcome [1] 381301 0
The patient's health-related quality of life following diagnosis will be assessed using the standardised Short-Form 36 Questionnaire (SF-36). It covers areas of physical and social functioning, physical and emotional limitations, bodily pain, general and mental health. It will take approximately 5 to 7 minutes to complete.
Timepoint [1] 381301 0
Follow up timepoints:
baseline
one week
3 months
6 months
1 year
and every 12 months thereafter for 10 years (end of registry), unless deceased, or consent withdrawn
Secondary outcome [2] 381302 0
The composite secondary outcome will include infection rate, endoleak and the need for repeat intervention. This will be assessed using data from analysis of surveillance imaging as well as review of medical records from outpatient follow-ups.
Timepoint [2] 381302 0
Follow up timepoints:
baseline
one week
3 months
6 months
1 year
and every 12 months thereafter for 10 years (end of registry), unless deceased, or consent withdrawn

Eligibility
Key inclusion criteria
Patients over the age 18 presenting at Royal North Shore Hospital, Sydney, NSW, and diagnosed with a type B aortic dissection. They must have given written consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not wish to participate or give consent.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
No sample size calculation required being a registry. Mortality data will be analysed using Kaplan-Meier curves. Prognostic factors will be analysed using Chi-square and Fisher exact tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305238 0
Government body
Name [1] 305238 0
Northern Sydney Local Health District
Address [1] 305238 0
Royal North Shore Hospital
Reserve Rd, St Leonards NSW 2065
Country [1] 305238 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Royal North Shore Hospital
Reserve Rd, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 305594 0
None
Name [1] 305594 0
Address [1] 305594 0
Country [1] 305594 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305581 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305581 0
Kolling Building
Level 13, Royal North Shore Hospital
Reserve Road, St Leonards NSW 2065
Ethics committee country [1] 305581 0
Australia
Date submitted for ethics approval [1] 305581 0
07/06/2018
Approval date [1] 305581 0
14/02/2019
Ethics approval number [1] 305581 0
RESP/18/150

Summary
Brief summary
This registry will include patients who present with an abnormality in the wall of their aorta (Type B aortic syndrome) with the aim of determining the natural history and clinical outcomes of this condition. Specifically, the group will look at the outcomes of patients who were treated with early intervention and/or basic medical therapy. From this study, the relationship between patient factors including kidney injury, and benefit from early intervention will be reported.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100850 0
Dr Vikram Puttaswamy
Address 100850 0
Clinical Trials Office
RNSH Vascular Surgery Research Office Admin Area 3E South
Royal North Shore Hospital
St Leonards
NSW 2065
Country 100850 0
Australia
Phone 100850 0
+61 2 9463 1767
Fax 100850 0
Email 100850 0
NSLHD-VascularSurgeryResearch@health.nsw.gov.au
Contact person for public queries
Name 100851 0
Ms Linda Pallot
Address 100851 0
RNSH Vascular Surgery Research Office Admin Area 3E South
Royal North Shore Hospital
St Leonards
NSW 2065
Country 100851 0
Australia
Phone 100851 0
+61 2 9463 1767
Fax 100851 0
Email 100851 0
Linda.Pallot@health.nsw.gov.au
Contact person for scientific queries
Name 100852 0
Dr David Arpon
Address 100852 0
RNSH Vascular Surgery Research Office Admin Area 3E South
Royal North Shore Hospital
St Leonards
NSW 2065
Country 100852 0
Australia
Phone 100852 0
+61 2 9463 1767
Fax 100852 0
Email 100852 0
NSLHD-VascularSurgeryResearch@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results