PROTECT-ICD: Preventing Sudden Cardiac Death After Heart Attack
The PROTECT-ICD study is looking at ways to prevent sudden cardiac death in people who have had a heart attack (myocardial infarction) and have weakened heart function. This study compares two approaches: one group receives an electrophysiology study (EPS), a procedure that tests the heart's electrical activity, to help decide if an implantable cardioverter-defibrillator (ICD) is needed. The other group receives standard care. Researchers will also use cardiac magnetic resonance (CMR) imaging to learn more about heart function. You may be eligible if you are 18-85 years old, had a heart attack 2-40 days ago, and have impaired left ventricular systolic function (LVEF≤40%). The study aims to see if these interventions reduce sudden cardiac death and non-fatal arrhythmias over two years.
- Study design
- This is a multi-center randomized controlled trial with a planned enrollment of 1058 participants. Participants will be assigned to either the intervention arm (EPS) or the control arm (standard care).
- What's involved
- Participants in the intervention arm will undergo an electrophysiology study (EPS) and a cardiac magnetic resonance (CMR) scan. The control group will receive ongoing standard care.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for two years after they join the study to track sudden cardiac death and non-fatal arrhythmia.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias Following Acute Myocardial Infarction (PROTECT-ICD)
At a glance
Conditions
Where it's being run
52 sites across 21 statesStudy leadership
- Study Principal Investigator Study Principal Investigator · PRINCIPAL_INVESTIGATOR · Western Sydney Local Health District
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Sudden cardiac death2 years after randomisation
Cause of death will be determined based on information obtained from witnesses, family members, death certificates, hospital records and autopsy or coroner reports. Sudden cardiac death will be explicitly defined as death that occurs "suddenly and unexpectedly" in a patient in otherwise stable condition and includes witnessed instantaneous deaths (with or without documentation of arrhythmia), unwitnessed deaths if the patient had been seen within 24 hours before death (in the absence of another clear cause of death), deaths caused by incessant ventricular tachyarrhythmia, deaths considered a sequel of cardiac arrest and deaths resulting from pro-arrhythmia of anti-arrhythmic drugs.31 The remainder of deaths will be classified as either non-sudden cardiovascular death, or non-cardiovascular death. Operative deaths associated with the implantation of an ICD will be counted as non-sudden cardiovascular death.
- Non-fatal arrhythmia2 years after randomisation
Non-fatal arrhythmia includes resuscitated cardiac arrest, sustained ventricular tachycardia (VT) and ventricular fibrillation (VF) in participants without an ICD. Resuscitated cardiac arrest is defined as a sudden circulatory arrest requiring cardiopulmonary resuscitation (CPR) (with or without documented arrhythmia) from which the patient regains consciousness. VT and VF are defined as ECG or telemetry-documented ventricular tachycardia or ventricular fibrillation. Only sustained ventricular tachycardia will be included (greater than 30 seconds of VT) or if the VT required emergency treatment with anti-arrhythmic medications or electrical cardioversion.