PROTECT-ICD Trial: Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias following Acute Myocardial Infarctio

Not Applicable

Recruiting

• Conditions: Sudden cardiac death; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12614000042640
• Lead Sponsor: Western Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1058

Inclusion Criteria

Participants will be 2-40 days (inclusive) following a myocardial infarct, with impaired left ventricular systolic function (Left Ventricular Ejection Fraction <=40% or at least moderately impaired).

Exclusion Criteria

* Pregnancy;
* Nursing home resident dependent on one or more activities of daily living;
* Significant non-cardiac co-morbidity with high likelihood of death within 1 year;
* Significant psychiatric illnesses that may be aggravated by device implantation or that may preclude regular follow up;
* Intravenous drug abuse (ongoing);
* Unresolved infection associated with risk for hematogenous seeding;
* Pre-existing implantable cardioverter-defibrillator (ICD);
* Secondary prevention indication for an ICD (i.e. sustained ventricular arrhythmias occurring more than 48 hours after qualifying myocardial infarction);
* On the heart transplant list;
* 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);
* 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be a combined endpoint of non-fatal arrhythmia and sudden cardiac death. Non-fatal arrhythmia includes resuscitated cardiac arrest, sustained ventricular tachycardia and ventricular fibrillation in participants without an ICD. [At 2 years after randomisation.]