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Procedure

Early ICD Implantation for Heart Attack (PROTECT-ICD Trial)

N/A

Recruiting

Led By Study Principal Investigator Study Principal Investigator

Research Sponsored by Western Sydney Local Health District

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Impaired left ventricular systolic function (LVEF≤40% or at least moderately impaired)

Be older than 18 years old

Must not have

Age <18 or >85

Significant non-cardiac co-morbidity with high likelihood of death within 1 year (this would include any metastatic malignancy, or other terminal disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years after randomisation

Awards & highlights

No Placebo-Only Group

Summary

This trial is assessing whether or not to give an ICD to patients who have had a myocardial infarction (heart attack) and have poor cardiac function. The trial will also assess the role of cardiac MRI in predicting risk of sudden cardiac death.

Who is the study for?

This trial is for adults aged 18-85 who've had a heart attack within the last 2-40 days and have reduced heart function (LVEF≤40%). It's not for pregnant women, nursing home residents dependent on care, those with terminal illnesses or drug abuse issues, unresolved infections, existing ICDs, unstable angina despite treatment, severe psychiatric illness, listed for heart transplant or severe untreatable shortness of breath.

What is being tested?

The PROTECT-ICD trial is testing whether an early electrophysiology study (EPS) can help decide if patients need an implantable cardioverter-defibrillator (ICD) after a heart attack to prevent sudden cardiac death. Some patients will also get a cardiac MRI to assess their risk. The goal is to see if this approach saves more lives compared to standard care.

What are the potential side effects?

Potential side effects are related to EPS procedures and ICD implantation which may include discomfort at the site of device insertion, infection risks from surgery or devices implanted in the body. Cardiac MRI has minimal risks but may cause discomfort due to its duration and noise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's pumping ability is reduced.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am younger than 18 or older than 85.

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I do not have a serious illness besides my cancer that could cause death within a year.

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I have ongoing chest pain despite treatment and procedures.

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I live in a nursing home and need help with daily activities.

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I currently have an infection that could spread through my blood.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years after randomisation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years after randomisation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years after randomisation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Non-fatal arrhythmia

Sudden cardiac death

Secondary study objectives

All-cause mortality

Appropriate ICD activations (in patients with ICD)

Complications or re-hospitalisation associated with ICD implantation (in patients with ICD)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Arm (Early EPS)Experimental Treatment2 Interventions

The intervention group all undergo electrophysiologic study early after myocardial infarction (within 40 days of MI). If the study is positive (inducible monomorphic ventricular tachycardia of cycle length greater than or equal to 200ms) participants have an ICD implanted. Participants with a negative study (no inducible arrhythmia or induced ventricular fibrillation/ ventricular flutter cycle length \<200ms) are discharged without an ICD. A proportion of trial patients from both the intervention and control arms at \>48 hours following revascularisation for STEMI will undergo CMR to enable correlation with (1) inducible VT at EPS and (2) SCD and non-fatal arrhythmia on follow up. CMR will simultaneously assess left ventricular function, ventricular strain, myocardial infarction size, and peri-infarction injury.

Group II: Control Arm (Standard Care)Active Control2 Interventions

The control group receive ongoing standard care according to the practise of their institution. This includes discharge from hospital as per their treating physician and follow up as usual in the community. Participants in this group would be eligible to receive an ICD according to the standard practise of their cardiologist (guideline recommendations are after 40 days following myocardial infarction or 90 days following revascularisation only in patients with left ventricular ejection fraction less than or equal to 30% or less than or equal to 35% in the presence of heart failure). A proportion of trial patients from both the intervention and control arms at \>48 hours following revascularisation for STEMI will undergo CMR to enable correlation with (1) inducible VT at EPS and (2) SCD and non-fatal arrhythmia on follow up. CMR will simultaneously assess left ventricular function, ventricular strain, myocardial infarction size, and peri-infarction injury.

0 / 6Eligibility criteria met