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Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias Following Acute Myocardial Infarction (PROTECT-ICD)
NCT03588286 · View on ClinicalTrials.gov ↗
Study Summary
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 predictor of mortality and spontaneous ventricular arrhythmia in patients with a previous MI. A total of 1,058 patients who are at high risk of SCD based on poor cardiac function (left ventricular ejection fraction (LVEF) ≤40%) following a ST-elevation or non-STE myocardial infarct will be enrolled in the trial. Patients will be randomised 1:1 to either the intervention or control arm. In the intervention arm all patients undergo early EPS. Patients with a positive study (inducible ventricular tachy
Conditions Studied
Interventions
- OTHER Standard Care
- PROCEDURE Electrophysiology study (EPS)
- PROCEDURE Cardiac Magnetic Resonance (CMR)
Study Locations (20)
Queensland
- Sunshine Coast University Hospital — Birtinya
- Carins Hospital — Cairns
- The Prince Charles Hospital — Chermside
- The Townsville Hospital — Douglas
- Royal Brisbane and Women's Hospital — Herston
- Gold Coast University Hospital — Southport
- Princess Alexandra Hospital — Woolloongabba
New South Wales
- Nepean Hospital — Kingswood
- John Hunter Hospital — New Lambton Heights
- Prince of Wales Hospital — Randwick
- Royal North Shore Hospital — Saint Leonards
- Westmead Hospital — Westmead
- Wollongong Hospital — Wollongong
Victoria
- MonashHeart — Clayton
- Northern Hospital — Epping
- Austin Hospital — Melbourne
- Western Health, Sunshine and Footscray Hospitals — Melbourne
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
Australian Capital Territory
- Canberra Hospital — Garran
South Australia
- Lyell McEwin Hospital — Elizabeth Vale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,058 participants |
| Start Date | 2014-02-27 |
| Est. Completion | 2029-12-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03588286
The ClinicalTrials.gov registry entry for NCT03588286 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,058 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Western Sydney Local Health District, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Sudden Cardiac Death appearing as the primary indexed condition, and to 3 interventions — of which Standard Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03588286 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Queensland, New South Wales, Victoria. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03588286 about?
NCT03588286 is a clinical study titled "Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias Following Acute Myocardial Infarction (PROTECT-ICD)". 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 ca...
What is the current status of trial NCT03588286?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,058 participants. The study started on 2014-02-27. Estimated completion is 2029-12-06.
What conditions does trial NCT03588286 study?
This clinical trial studies the following conditions: Sudden Cardiac Death. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03588286?
The interventions under investigation include: Standard Care (OTHER), Electrophysiology study (EPS) (PROCEDURE), Cardiac Magnetic Resonance (CMR) (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03588286?
This trial is sponsored by Western Sydney Local Health District, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03588286 being conducted?
This trial has 20 study locations across Massachusetts, Australian Capital Territory, New South Wales, Queensland, South Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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