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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years after randomisation

Awards & highlights

PROTECT-ICD Trial 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.Check my eligibility

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.See study design

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.

PROTECT-ICD Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My heart's pumping ability is reduced.

PROTECT-ICD Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Non-fatal arrhythmia

Sudden cardiac death

Secondary outcome measures

All-cause mortality

Appropriate ICD activations (in patients with ICD)

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

+5 more

PROTECT-ICD 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Western Sydney Local Health DistrictLead Sponsor

39 Previous Clinical Trials

17,457 Total Patients Enrolled

Study Principal Investigator Study Principal InvestigatorPrincipal InvestigatorWestern Sydney Local Health District

Media Library

Electrophysiology study (EPS) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03588286 — N/A

Sudden Cardiac Death Research Study Groups: Control Arm (Standard Care), Intervention Arm (Early EPS)

Sudden Cardiac Death Clinical Trial 2023: Electrophysiology study (EPS) Highlights & Side Effects. Trial Name: NCT03588286 — N/A

Electrophysiology study (EPS) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03588286 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals enrolled in this medical experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this medical trial is actively seeking participants who meet its criteria. The post was first published on February 27th 2014 and last amended on April 27th 2022, with a target enrolment of 1058 patients at 1 location."

Answered by AI

Is it permissible for those aged under 75 to engage in this experiment?

"The qualifications for this study necessitate that participants are between 18 and 85 years of age. There are 48 studies available to minors, while people over 65 can choose from 515 different options."

Answered by AI

Are there opportunities to join this experiment presently?

"Yes, clinicaltrials.gov supports the fact that this research is actively recruiting for 1058 participants from a single medical site. The trial was initially submitted on February 27th 2014 and its information has been updated most recently on April 27 2022."

Answered by AI

What are the central aims of this research endeavor?

"This randomised trial will assess the rate of sudden cardiac death during a two-year observation period. Secondary objectives include measuring any complications or rehospitalisations associated with ICD implantation (in patients with one) as well as inappropriate activations and all-cause mortality."

Answered by AI

What are the criteria for joining this scientific experiment?

"To meet the inclusion criteria for this medical trial, candidates must have suffered from sudden cardiac arrest and be aged between 18 and 85. The total amount of participants expected to take part is 1058 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Pramesh Kovoor 2014. "Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias Following Acute Myocardial Infarction (PROTECT-ICD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03588286.

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