Condition: Sudden Cardiac Death · Sponsor: Western Sydney Local Health District
The PROTECT-ICD trial is a physician-led, multi-centre randomised controlled trial targeting prevention of sudden cardiac death in patients who have poor cardiac function following a myocardial infarct (MI). The trial aims to assess the role of electrophysiology study (EPS) in guiding implantable cardioverter-defibrillator (ICD) implantation, in patients early following MI (first 40 days). The secondary aim is to assess the utility of cardiac MRI (CMR) in analysing cardiac function and viability as well as predicting inducible and spontaneous ventricular tachyarrhythmia when performed early post MI. Following a MI patients are at high risk of sudden cardiac death (SCD). The risk is highest in the first 40 days; however, current guidelines exclude patients from receiving an ICD during this time. This limitation is based largely on a single study, The Defibrillator in Acute Myocardial Infarction Trial (DINAMIT), which failed to demonstrate a benefit of early ICD implantation. However, this study was underpowered and used non-invasive tests to identify patients at high risk. EPS identifies patients with the substrate for re-entrant tachyarrhythmia, and has been found in multiple studies to predict patients at risk of SCD. Contrast-enhanced CMR is a non-invasive test without radiation exposure which can be used to assess left ventricular function. In addition, it provides information on myocardial viability, scar size and tissue heterogeneity. It has an emerging role as a predic…
This description comes directly from the study's public registry record.
Pramesh Kovoor · +61 2 8890 6030 · pramesh.kovoor@sydney.edu.au
Anjalee T Amarasekera · +61 2 8890 4719 · Anjalee.Amarasekera@health.nsw.gov.au
Always discuss trial participation with your own doctor first.
| Beth Israel Deaconess Medical Center | Boston, Massachusetts, United States | Not Yet Recruiting |
| Canberra Hospital | Garran, Australian Capital Territory, Australia | Recruiting |
| Nepean Hospital | Kingswood, New South Wales, Australia | Recruiting |
| John Hunter Hospital | New Lambton Heights, New South Wales, Australia | Recruiting |
| Prince of Wales Hospital | Randwick, New South Wales, Australia | Recruiting |
| Royal North Shore Hospital | Saint Leonards, New South Wales, Australia | Recruiting |
| Westmead Hospital | Westmead, New South Wales, Australia | Recruiting |
| Wollongong Hospital | Wollongong, New South Wales, Australia | Recruiting |
| Sunshine Coast University Hospital | Birtinya, Queensland, Australia | Recruiting |
| Carins Hospital | Cairns, Queensland, Australia | Recruiting |
| The Prince Charles Hospital | Chermside, Queensland, Australia | Recruiting |
| The Townsville Hospital | Douglas, Queensland, Australia | Recruiting |
+ 40 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03588286