Using heart tests to decide on defibrillator implantation after a heart attack

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PROTECT-ICD trial is a multi-centre randomized controlled trial aimed at preventing sudden cardiac death in patients with poor cardiac function following a myocardial infarction. It evaluates the effectiveness of electrophysiology studies (EPS) in guiding the early implantation of implantable cardioverter-defibrillators (ICDs) within the first 40 days post-MI. Additionally, the study assesses the role of cardiac MRI in analyzing cardiac function and predicting arrhythmias. This approach seeks to address the current guidelines that restrict ICD implantation during this critical period despite the high risk of sudden cardiac death.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

+2 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Study Principal Investigator Study Principal Investigator — Western Sydney Local Health District
• Study coordinator: Pramesh Kovoor
• Email: pramesh.kovoor@sydney.edu.au
• Phone: +61 2 8890 6030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.