The Australian New Zealand Spontaneous Coronary Artery Dissection (ANZ-SCAD) Registry

• Register: ANZCTR
• Last refreshed on: 5 July 2021
• Main ID: ACTRN12621000824864
• Date of registration: 28/06/2021
• Prospective Registration: Yes
• Primary sponsor: The University of Sydney
• 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
• Date of first enrolment: 01/07/2021
• Target sample size: 850
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12621000824864.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Both;
• Phase: Not Applicable

Countries of recruitment

Australia, New Zealand

Contacts

• Name: Ms Swetha Perera

• Name: Ms Swetha Perera

Key inclusion & exclusion criteria

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

Exclusion criteria: Exclusion criteria
• Participants will be consequently excluded if core angiographic review suggests iatrogrenic,
atherosclerotic or another alternate cause of dissection.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cardiovascular - Coronary heart disease

Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

Spontaneous Coronary Artery Dissection;
Spontaneous Coronary Artery Dissection

Intervention(s)

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 eith

Primary Outcome(s)

data collection of how SCAD patients clinically present to the hospital.
[ This will be determined from medical records from hospital admission. Baseline ( diagnosis of SCAD), ]

management of patients diagnosed with SCAD. [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]

treatment outcomes for patients diagnosed with SCAD. [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(s)

Measure angina score using Seattle Angina Questionnaire[1 year and 2 year post enrolment into registry]

Quality of life assessed using EQ-5D Quality of life Questionnaire post SCAD diagnosis[30 days post enrolment into registry ]

To assess if ethnic variability exists in patients presenting to hospital with Spontaneous Coronary Artery Dissection.
[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.]

To assess rates of long term recurrence of Spontaneous Coronary Artery Dissection within different ethinic populations. [ 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.]

To explore if there are any pre-disposing risk factors that result in Spontaneous Coronary Artery Dissection. [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 ID(s)

NIL known

Source(s) of Monetary Support

NSW Health

Ethics review

Status: Approved
Approval date: 24/02/2021
Contact:

western Sydney Local Health District