Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias Following Acute Myocardial Infarction (PROTECT-ICD)

Launched by WESTERN SYDNEY LOCAL HEALTH DISTRICT · Jul 4, 2018

Keywords

ClinConnect Summary

The PROTECT-ICD trial is studying whether a special heart test called electrophysiology study (EPS) can help doctors decide if patients need an implantable cardioverter-defibrillator (ICD) soon after having a heart attack (myocardial infarction). This trial focuses on patients who have weakened heart function (specifically, a left ventricular ejection fraction of 40% or less) within the first 40 days after their heart attack. The goal is to find out if using EPS to identify patients at high risk of sudden cardiac death can lead to better outcomes compared to standard care, where patients are typically monitored and may not receive an ICD right away.

To participate in the trial, patients must be between 18 and 85 years old, have recently experienced a heart attack, and have impaired heart function. They will be divided into two groups: one will receive the EPS test to determine if they should get an ICD, while the other will follow standard treatment practices. All participants will be monitored for two years to track important health outcomes, including any episodes of dangerous heart rhythms or sudden cardiac death. The results of this study may help change medical guidelines and ultimately save lives by ensuring that those who need an ICD receive it as soon as possible.

Gender

ALL

Eligibility criteria

• 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.