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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)

RecruitingNAAges 18 Years - 85 YearsAllWestern Sydney Local Health District
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In plain words

What the trial is, and whether it could suit you

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 Inf

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 2-40 days (inclusive) following a myocardial infarct * Impaired left ventricular systolic function (LVEF≤40% or at least moderately impaired) Exclusion Criteria: 1. Age \<18 or \>85; 2. Pregnancy; 3. Nursing home resident dependent on one or more activities of daily living; 4. Significant non-cardiac co-morbidity with high likelihood of death within 1 year (this would include any metastatic malignancy, or other terminal disease); 5. Significant psychiatric illnesses that may be aggravated by device implantation or that may preclude regular follow up; 6. Intravenous drug abuse (ongoing); 7. Unresolved infection associated with risk for hematogenous seeding; 8. Pre-existing implantable cardioverter-defibrillator (ICD); 9. Secondary prevention indication for an ICD (i.e. sustained ventricular arrhythmias occurring more than 48 hours after qualifying myocardial infarction (patients with ventricular arrhythmias occurring ≤48 hours of myocardial infarction, or with non-sustained ventricular tachycardia at any time, are not excluded)); 10. On the heart transplant list; 11. Recurrent unstable angina despite revascularisation (defined as ongoing chest pain or ischemic symptoms at rest or with minimal exertion despite adequate treatment with anti-anginal medications);\*\* 12. Congestive heart failure New York Heart Association class IV, defined as shortness of breath at rest, which is refractory to medical treatment (not responding to treatment)\*\* \*\*NOTE: patients who meet exclusion based on (11) or (12) can be reviewed again in 2-3 days and if symptoms have resolved or treatment performed can be re-considered for inclusion.
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What it tests

  • Electrophysiology study (EPS)
  • Standard Care
  • Cardiac Magnetic Resonance (CMR)
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Where

52 sites
Beth Israel Deaconess Medical Center
Boston, United States
Canberra Hospital
Garran, Australia
Nepean Hospital
Kingswood, Australia
John Hunter Hospital
New Lambton Heights, Australia
Prince of Wales Hospital
Randwick, Australia
Royal North Shore Hospital
Saint Leonards, Australia
Westmead Hospital
Westmead, Australia
Wollongong Hospital
Wollongong, Australia

…and 44 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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