Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000824864
Ethics application status
Approved
Date submitted
25/03/2021
Date registered
28/06/2021
Date last updated
18/11/2022
Date data sharing statement initially provided
28/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Australian New Zealand Spontaneous Coronary Artery Dissection (ANZ-SCAD) Registry
Scientific title
The Australian New Zealand Spontaneous Coronary Artery Dissection (ANZ-SCAD) Registry
Secondary ID [1] 303790 0
NIL known
Universal Trial Number (UTN)
Trial acronym
ANZ-SCAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spontaneous Coronary Artery Dissection 321877 0
Condition category
Condition code
Cardiovascular 319078 319078 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 319604 319604 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
This project will pilot the first ever Australian-New Zealand Spontaneous Coronary Artery Dissection (ANZ-SCAD) Registry. Patients will be recruited from each individual site with their baseline clinical data entered locally by a study coordinator and captured onto an online centralised database. Baseline data includes background medical history (including known pre-disposing genetic conditions), cardiovascular risk factors, medications at baseline and on discharge, presentation, triggers, investigations (including CTCA and CMR), management (including revascularisation) and in-hospital outcomes. In-hospital pathology results will be collected including serum creatinine and electrolytes, liver function, full blood count, high sensitivity C-reactive protein (hs-CRP), fasting lipids (TC, LDL, HDL, triglycerides) and diabetic profiles will be collected for all patients.
For retrospective patients, data will be collected from their respective treating hospital from 1st Mar 2011 to date. There are 18 recruiting sites in total across Australia and New Zealand.

Prospective patients will be recruited ongoing from their treating hospital upon admission with a diagnosis of SCAD. Follow up will be performed at 30days, 1 year and early there after for upto 5years. Questionnaire will be sent directly to participants to collect their pre- and post-SCAD family and medical history, exercise, stress, quality of life and medication use data. Retrospectively recruited patients will not have ongoing follow up, with the date of last follow up or death taken from the available medical records at the time of recruitment. In hospital scans, angiograms and procedures data will be collected for all participants. As this is an observational study, all data will be collected either from participants medical records or questionnaires. No additional tests and cardiac scans for this study purpose will be required.
The follow-up will be largely electronic by participants receiving an email link to a secure survey generated by the REDCap database that assess self-reported outcomes. Telephone contact will be performed when required by each site if participants are unable to complete the survey. This will be with the use of telephone interpreters as needed for those of Non-English speaking backgrounds, and hospital/medical records obtained to clarify diagnoses, as required. Thirty day follow up will include a Quality of Life (QoL) assessment using the EQ-5D questionnaire. A Seattle Angina Questionnaire will be used at 1 and 2 year follow-ups. Clinical outcomes will be total and cardiac mortality, SCAD recurrence, major adverse cardiovascular events (MACE) and major adverse cardiac and cerebrovascular events (MACCE).
Participants recruited retrospectively will not be consented. Waiver of consent has been obtained from relevant ethics committee. Participants will not be contacted.

Patients with a clinical diagnosis of SCAD based on presentation features and confirmed on coronary angiography is eligible for this study. Coronary angiogram and procedure reports will be collected from participants electronic medical records
Intervention code [1] 320094 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326965 0
data collection of how SCAD patients clinically present to the hospital.
Timepoint [1] 326965 0
This will be determined from medical records from hospital admission. Baseline ( diagnosis of SCAD),
Primary outcome [2] 327462 0
management of patients diagnosed with SCAD.
Timepoint [2] 327462 0
This will be determined from medical records and from participant surveys conducted at baseline, 30days, 1year and yearly there after for upto 5 years post-enrolment into registry
Primary outcome [3] 327819 0
treatment outcomes for patients diagnosed with SCAD.
Timepoint [3] 327819 0
This will be determined from medical records and from participant surveys conducted
at 30days, 1year and yearly there after for upto 5 years post-enrolment into registry
Secondary outcome [1] 393315 0
To assess if ethnic variability exists in patients presenting to hospital with Spontaneous Coronary Artery Dissection.
Timepoint [1] 393315 0
This will be dertermine from medical records at hospital and baseline questionnaire that collects medical and family history at enrolment/baseline for prospectively recruited participants.
Secondary outcome [2] 395180 0
To explore if there are any pre-disposing risk factors that result in Spontaneous Coronary Artery Dissection.
Timepoint [2] 395180 0
Baseline medical history/family/lifestyle questionnaire will be sent to prospectively recruited participant via a email and also determine from medical records at hospital at enrolment into registry
Secondary outcome [3] 396868 0
To assess rates of long term recurrence of Spontaneous Coronary Artery Dissection within different ethinic populations.
Timepoint [3] 396868 0
Study-specific questionnaire will be used to determine the recurrence within different populations at 1 year and yearly there after for upto 5 years post-enrolment into registry.
Secondary outcome [4] 396869 0
Quality of life assessed using EQ-5D Quality of life Questionnaire post SCAD diagnosis
Timepoint [4] 396869 0
30 days post enrolment into registry
Secondary outcome [5] 396870 0
Measure angina score using Seattle Angina Questionnaire
Timepoint [5] 396870 0
1 year and 2 year post enrolment into registry

Eligibility
Key inclusion criteria
Inclusion criteria
• Participants aged =>18 years who present to hospital with an acute coronary syndrome
(ACS)
• Able to provide informed consent (for prospectively recruited patients only)
• Clinical and angiographically confirmed SCAD diagnosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
• Participants will be consequently excluded if core angiographic review suggests iatrogrenic,
atherosclerotic or another alternate cause of dissection.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
2/09/2021
Date of last participant enrolment
Anticipated
30/05/2026
Actual
Date of last data collection
Anticipated
30/05/2027
Actual
Sample size
Target
850
Accrual to date
245
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,SA,WA,VIC
Recruitment hospital [1] 19005 0
Westmead Hospital - Westmead
Recruitment hospital [2] 19006 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 19007 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 19008 0
John Hunter Hospital - New Lambton
Recruitment hospital [5] 19009 0
Blacktown Hospital - Blacktown
Recruitment hospital [6] 19010 0
Orange Health Service - Orange
Recruitment hospital [7] 19011 0
Gosford Hospital - Gosford
Recruitment hospital [8] 19012 0
Box Hill Hospital - Box Hill
Recruitment hospital [9] 19013 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [10] 19014 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [11] 19015 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [12] 19686 0
Monash Surgical Private Hospital - Clayton
Recruitment hospital [13] 19688 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [14] 19689 0
The Alfred - Melbourne
Recruitment hospital [15] 19690 0
Peninsula Private Hospital - Frankston - Frankston
Recruitment hospital [16] 19691 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [17] 21061 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 33549 0
2145 - Westmead
Recruitment postcode(s) [2] 33550 0
2747 - Kingswood
Recruitment postcode(s) [3] 33551 0
2170 - Liverpool
Recruitment postcode(s) [4] 33552 0
2305 - New Lambton
Recruitment postcode(s) [5] 33553 0
2148 - Blacktown
Recruitment postcode(s) [6] 33554 0
2800 - Orange
Recruitment postcode(s) [7] 33555 0
2250 - Gosford
Recruitment postcode(s) [8] 33556 0
3128 - Box Hill
Recruitment postcode(s) [9] 33557 0
6150 - Murdoch
Recruitment postcode(s) [10] 33558 0
0810 - Tiwi
Recruitment postcode(s) [11] 33559 0
5000 - Adelaide
Recruitment postcode(s) [12] 34318 0
3168 - Clayton
Recruitment postcode(s) [13] 34320 0
3144 - Malvern
Recruitment postcode(s) [14] 34321 0
3199 - Frankston
Recruitment postcode(s) [15] 34322 0
2065 - St Leonards
Recruitment postcode(s) [16] 35908 0
2031 - Randwick
Recruitment outside Australia
Country [1] 23566 0
New Zealand
State/province [1] 23566 0

Funding & Sponsors
Funding source category [1] 308194 0
Government body
Name [1] 308194 0
NSW Health
Country [1] 308194 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 308973 0
None
Name [1] 308973 0
Address [1] 308973 0
Country [1] 308973 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308174 0
western Sydney Local Health District
Ethics committee address [1] 308174 0
WSLHD Research and Education Network,
Westmead Hospital,
Hawkesbury Road,
Westmead NSW 2145
Ethics committee country [1] 308174 0
Australia
Date submitted for ethics approval [1] 308174 0
Approval date [1] 308174 0
24/02/2021
Ethics approval number [1] 308174 0
2021/ETH00040

Summary
Brief summary
Spontaneous coronary artery dissection (SCAD) is a dissection of the coronary artery with formation of an intramural haematoma or ‘false’ lumen. The resultant obstruction to myocardial blood supply leads to acute coronary syndrome (ACS) or sudden death. SCAD has a strong female predominance, with up to 90% of cases women; the majority young and healthy without cardiovascular risk factors. It is this predilection for younger women that has played a part in SCAD being universally under-recognised and under-researched. Whilst we now appreciate that SCAD is not a rare disease, the bigger problem is that we know little about how to prevent or treat it. Clinical SCAD research is urgently needed if we are to uncover more than just the tip of the iceberg in this complex and life-threatening disease. This project will pilot the first ever Australian-New Zealand Spontaneous Coronary Artery Dissection (ANZ-SCAD) Registry. 850 SCAD patients will be recruited from 10-15 hospitals across Australia/NZ with both retrospective (historical cases) and prospective case enrolment. These patients will be recruited from the study sites.

Patients will be identified using their medical records and hospital admission with a diagnosis of SCAD. Background medical history (including known pre-disposing genetic conditions), cardiovascular risk factors, medications at baseline and on discharge, presentation, triggers, investigations ( i.e. scans, angiogram, including management (including revascularisation) and in-hospital outcomes. In-hospital pathology results and diabetic profiles will be collected from the medical records. For Prospectively recruited participantst follow up- information such as patients detailed family and medical history, excercise, stress pre- and post- SCAD, quality of life will be collected via questionnaires for a duration of 5 years. No follow up will be performed for retrospectively recruited participants, with all data about treatment and survival taken from medical records.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109802 0
A/Prof Sarah Zaman
Address 109802 0
Westmead Applied Research Centre,
Level 6, Block K, Entrance 10, Westmead Hospital,
Hawkesbury Road, Westmead, NSW, 2145
Country 109802 0
Australia
Phone 109802 0
+61 414365523
Fax 109802 0
Email 109802 0
[email protected]
Contact person for public queries
Name 109803 0
Ms Swetha Perera
Address 109803 0
Westmead Applied Research Centre,
Level 6, Block K, Entrance 10, Westmead Hospital,
Hawkesbury Road, Westmead, NSW, 2145
Country 109803 0
Australia
Phone 109803 0
+61 433510318
Fax 109803 0
Email 109803 0
[email protected]
Contact person for scientific queries
Name 109804 0
Ms Swetha Perera
Address 109804 0
Westmead Applied Research Centre,
Level 6, Block K, Entrance 10, Westmead Hospital,
Hawkesbury Road, Westmead, NSW, 2145
Country 109804 0
Australia
Phone 109804 0
+61 433510318
Fax 109804 0
Email 109804 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
IPD will not be available publicly. All de-indetified data will be collected for analysis and for data pooling with international collaborators.


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
SourceTitleYear of PublicationDOI
EmbaseThe Australian New Zealand Spontaneous Coronary Artery Dissection (ANZ-SCAD) Registry - A Multi-Centre Cohort Study: Protocol, Background and Significance.2022https://dx.doi.org/10.1016/j.hlc.2022.08.018
N.B. These documents automatically identified may not have been verified by the study sponsor.