RecruitingACTRN12621000824864

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

Sponsor

The University of Sydney

Enrollment

850 participants

Start Date

Sep 2, 2021

Study Type

Observational

Conditions

Spontaneous Coronary Artery Dissection

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Spontaneous coronary artery dissection (SCAD) is a rare but life-threatening condition where a tear forms inside a coronary artery, creating a false passage that blocks blood flow to the heart. Unlike the typical heart attack caused by fatty plaques, SCAD predominantly affects young, healthy women — often with no traditional heart disease risk factors. Despite this, it remains vastly under-recognised and under-researched. The ANZ-SCAD Registry is the first national registry for this condition in Australia and New Zealand. It aims to collect detailed clinical information from 850 SCAD patients across 10-15 hospitals, both looking back at historical cases and enrolling new patients going forward. The registry will examine triggers, associated conditions, treatment approaches, and long-term outcomes. You may be eligible if you are 18 or older and have been diagnosed with SCAD confirmed by coronary angiogram. Retrospective participants (past cases) will have data collected from medical records. Prospectively enrolled patients will be followed up for 5 years with questionnaires. People whose angiogram review suggests an alternative cause for the dissection (not SCAD) are excluded.

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Interventions

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