None listed
Conditions
Brief summary
The PROTECT-ICD study is a multi-centre randomised controlled trial targeting prevention of sudden cardiac death in patients who have reduced cardiac function following a myocardial infarct. The primary objective of the trial is to assess whether electrophysiologic study to guide prophylactic implantation of an implantable cardioverter-defibrillator early following MI (first 40 days) will lead to a significant reduction in sudden cardiac death. The secondary objective is to assess the utility of cardiac magnetic resonance imaging in assessing early myocardial viability, and its predictive value for both inducible and spontaneous ventricular tachyarrhythmias post-myocardial infarction.
Interventions
The intervention group all undergo electrophysiologic study early after myocardial infarction (within 40 days of MI). The electrophysiology study is done in a hospital laboratory by a specialist cardiologist under local anaesthetic and sedation given through a cannula. A sheath will be placed into the vein in the groin. The Cardiologist will then place 2 electrode catheters into the heart with the use of x-ray images to carefully guide the catheters into the proper areas. The electrode catheters
The intervention group all undergo electrophysiologic study early after myocardial infarction (within 40 days of MI). The electrophysiology study is done in a hospital laboratory by a specialist cardiologist under local anaesthetic and sedation given through a cannula. A sheath will be placed into the vein in the groin. The Cardiologist will then place 2 electrode catheters into the heart with the use of x-ray images to carefully guide the catheters into the proper areas. The electrode catheters will be used to stimulate the heart and record the electrical activity. This test will take approximately one hour. The patient will generally stay overnight in hospital and go home the next day. If the study is positive (inducible monomorphic ventricular tachycardia of cycle length less 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. Implantation of an ICD device involves positioning leads in the heart and placing a box device under the skin, usually in the shoulder area. The procedure is done in a hospital laboratory by a specialist cardiologist under local anaesthetic and with sedation through an intravenous cannula. The leads are inserted through a small incision, usually near the collarbone. X-ray images are used to guide the lead/s into the heart. These leads are attached to the device box which is then placed just beneath the skin and the incision closed with stitches. The patient will often stay overnight in hospital and go home the next day. The device remains in situ for the remainder of the patient's life, barring any complications that would require it's removal. At select centres a proportion of trial patients at >48 hours following revascularisation for myocardial infarction will also undergo cardiac magnetic resonance imaging (CMR). This is a non-invasive painless test which does not involve any radiation. A series of images will be taken of the heart while positioned on a moveable examination table. The test will take 30-45 minutes and in most cases will involve injection of a contrast material into an intravenous line.
Sponsors
Western Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Outcome results
None listed