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New treatment option for Sudden Cardiac Death
Official title Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias Following Acute Myocardial Infarction (PROTECT-ICD)
ClinicalTrials.gov ID: NCT03588286
What this study is testing
- What it's testing
- The PROTECT-ICD trial is a physician-led, multi-centre randomised controlled trial targeting prevention of sudden cardiac death in patients who have poor cardiac function following a myocardial infarct (MI). The trial aims to assess the role of electrophysiology study (EPS) in guiding implantable cardioverter-defibrillator (ICD) implantation, in patients early following MI (first 40 days).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 2-40 days (inclusive) following a myocardial infarct
- Impaired left ventricular systolic function (LVEF≤40% or at least moderately impaired)
You likely can't join if
- Age \ 85;
- 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 (this would include any metastatic malignancy, or other terminal...
- Significant psychiatric illnesses that may be aggravated by device implantation or that may preclude regular follow up;
- Intravenous drug abuse (ongoing);
See the full eligibility criteria
- 2-40 days (inclusive) following a myocardial infarct
- Impaired left ventricular systolic function (LVEF≤40% or at least moderately impaired)
- Age \ 85;
- 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 (this would include any metastatic malignancy, or other terminal disease);
- 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 (patients with ventricular arrhythmias occurring ≤48 hours of...
- 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)\ \ \ \ NOTE: patients who meet exclusion based...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Garran, Australian Capital Territory, Australia
- Kingswood, New South Wales, Australia
- New Lambton Heights, New South Wales, Australia
- Randwick, New South Wales, Australia
- Saint Leonards, New South Wales, Australia
- Westmead, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Birtinya, Queensland, Australia
- Cairns, Queensland, Australia
- Chermside, Queensland, Australia
- Douglas, Queensland, Australia
- Herston, Queensland, Australia
- Southport, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Elizabeth Vale, South Australia, Australia
- Clayton, Victoria, Australia
- Epping, Victoria, Australia
- Melbourne, Victoria, Australia
- Prague, Czechia
+ 26 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Garran, Australian Capital Territory, Australia; Kingswood, New South Wales, Australia; New Lambton Heights, New South Wales, Australia; Randwick, New South Wales, Australia; Saint Leonards, New South Wales, Australia and 40 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.