Cardiovascular Circulatory System
Conditions
Interventions
Patients will be randomised in a 1:1 ratio to receive either ICD implantation with conventional medical therapy versus conventional medical therapy alone. All patients will be treated with optimised d
Sponsors
Individual Sponsor (Netherlands)
Eligibility
Inclusion criteria
Inclusion criteria: 1. ST-elevation myocardial infarction treated with primary PCI within 30 days and 60 days before randomisation 2. At least one of the following criteria: a. Thrombolysis In Myocardial Infarction (TIMI) flow after primary PCI less than three in the infarct related vessel b. Left ventricular ejection lower than 30% as measured within four days after admission
Exclusion criteria
Exclusion criteria: 1. Class I indication for ICD implantation 2. Documented previous myocardial infarction with Left Ventricular Ejection Fraction (LVEF) less than 30% 3. Age less than 18 years 4. Heart failure with New York Heart Association functional class IV 5. Inotropic medication within two weeks before randomisation 6. Mechanical tricuspid valve 7. Serious comorbidity such as cancer, with a high likelihood of death during the trial 8. Advanced cerebrovascular disease 9. Unwilling or unable to sign the consent form for participation 10. Females of childbearing age not using medically prescribed contraceptives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is all-cause mortality. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the incidence of sudden cardiac death and sustained Ventricular Tachycardia (VT). Sudden cardiac death is defined as occurring within one hour of the onset of symptoms or, if death is not witnessed, during sleep or within 24 hours of last occasion on which the patient was seen in a healthy state. | — |
Countries
Netherlands
Outcome results
None listed